| 2026-08-21 |
Class II
|
Ongoing |
Z-3243-2026 |
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia… |
— |
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req… |
| 2026-08-21 |
Class II
|
Ongoing |
Z-3242-2026 |
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade); |
— |
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req… |
| 2026-08-21 |
Class II
|
Ongoing |
Z-3241-2026 |
MR 5300 Model Number (REF): 1. 782110, 2. 782152; |
— |
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req… |
| 2026-08-21 |
Class II
|
Ongoing |
Z-3240-2026 |
Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Inter… |
— |
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req… |
| 2026-08-21 |
Class II
|
Ongoing |
Z-3239-2026 |
Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5… |
— |
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req… |
| 2026-08-21 |
Class II
|
Ongoing |
Z-3238-2026 |
Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0… |
— |
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req… |
| 2026-08-21 |
Class II
|
Ongoing |
Z-3237-2026 |
Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 … |
— |
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req… |
| 2026-08-21 |
Class II
|
Ongoing |
Z-3236-2026 |
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T… |
— |
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req… |
| 2026-08-21 |
Class II
|
Ongoing |
Z-3235-2026 |
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (… |
— |
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req… |
| 2026-08-21 |
Class II
|
Ongoing |
Z-3234-2026 |
Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253; |
— |
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req… |
| 2026-08-21 |
Class II
|
Ongoing |
Z-3233-2026 |
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345; |
— |
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req… |
| 2026-08-21 |
Class II
|
Ongoing |
Z-3232-2026 |
Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2… |
— |
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req… |
| 2026-08-07 |
Class II
|
Ongoing |
Z-3043-2026 |
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232.… |
— |
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of th… |
| 2026-08-07 |
Class II
|
Ongoing |
Z-3042-2026 |
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elit… |
— |
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of th… |
| 2026-08-07 |
Class II
|
Ongoing |
Z-3041-2026 |
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x |
— |
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of th… |
| 2026-08-07 |
Class II
|
Ongoing |
Z-3040-2026 |
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Co… |
— |
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of th… |
| 2026-06-05 |
Class II
|
Ongoing |
Z-2579-2026 |
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5… |
— |
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to… |
| 2026-05-26 |
Class II
|
Ongoing |
Z-2523-2026 |
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A |
— |
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or p… |
| 2026-05-26 |
Class II
|
Ongoing |
Z-2522-2026 |
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A |
— |
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or p… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1969-2026 |
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130. |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1968-2026 |
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Numbe… |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1967-2026 |
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model… |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1966-2026 |
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145. |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1965-2026 |
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number… |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1964-2026 |
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153. |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1963-2026 |
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 7821… |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1962-2026 |
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 7821… |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1961-2026 |
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782… |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1960-2026 |
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782… |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1959-2026 |
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105… |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1958-2026 |
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. … |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1957-2026 |
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262. |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1956-2026 |
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. … |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1955-2026 |
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF):… |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1954-2026 |
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 7… |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1953-2026 |
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278. |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1952-2026 |
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178. |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-04-14 |
Class II
|
Ongoing |
Z-1951-2026 |
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296. |
— |
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to… |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1318-2026 |
Spectral CT 7500 on Rails; Product Code (REF): 728334; |
— |
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners … |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1317-2026 |
Spectral CT; Product Code (REF): 728333; |
— |
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners … |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1316-2026 |
IQon Spectral CT; Product Code (REF): 728332; |
— |
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners … |
| 2026-01-07 |
Class II
|
Ongoing |
Z-1315-2026 |
Brilliance iCT; Product Code (REF): 728306; |
— |
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners … |
| 2025-12-22 |
Class II
|
Ongoing |
Z-1156-2026 |
Patient Information Center iX; Software Version Number: 4.5.0 |
— |
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system. |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1033-2026 |
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. |
— |
It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength chang… |
| 2025-12-03 |
Class II
|
Ongoing |
Z-1216-2026 |
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1. |
— |
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| 2025-12-03 |
Class II
|
Ongoing |
Z-1215-2026 |
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1. |
— |
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| 2025-12-03 |
Class II
|
Ongoing |
Z-1214-2026 |
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1. |
— |
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| 2025-12-03 |
Class II
|
Ongoing |
Z-1213-2026 |
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1. |
— |
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| 2025-12-03 |
Class II
|
Ongoing |
Z-1212-2026 |
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.… |
— |
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| 2025-12-03 |
Class II
|
Ongoing |
Z-1211-2026 |
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1… |
— |
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| 2025-12-03 |
Class II
|
Ongoing |
Z-1210-2026 |
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.… |
— |
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| 2025-12-03 |
Class II
|
Ongoing |
Z-1209-2026 |
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1. |
— |
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| 2025-12-03 |
Class II
|
Ongoing |
Z-1208-2026 |
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1. |
— |
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| 2025-12-03 |
Class II
|
Ongoing |
Z-1207-2026 |
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1. |
— |
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| 2025-12-03 |
Class II
|
Ongoing |
Z-1206-2026 |
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1. |
— |
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| 2025-12-03 |
Class II
|
Ongoing |
Z-1205-2026 |
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1. |
— |
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| 2025-12-03 |
Class II
|
Ongoing |
Z-1204-2026 |
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1. |
— |
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0870-2026 |
IntelliVue Patient Monitor MX850. Product Number: 866470. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0869-2026 |
IntelliVue Patient Monitor MX800. Product Number: 865240. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0868-2026 |
IntelliVue Patient Monitor MX750. Product Number: 866471. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0867-2026 |
IntelliVue Patient Monitor MX700. Product Number: 865241. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0866-2026 |
IntelliVue Patient Monitor MX600. Product Number: 865242. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0865-2026 |
IntelliVue Patient Monitor MX550. Product Number: 866066. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0864-2026 |
IntelliVue Patient Monitor MX500. Product Number: 866064. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0863-2026 |
IntelliVue Patient Monitor MX450. Product Number: 866062. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0862-2026 |
IntelliVue Patient Monitor MX400. Product Number: 866060. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0861-2026 |
IntelliVue Patient Monitor MX100. Product Number: 867033. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0860-2026 |
IntelliVue Multi-Measurement Module X3. Product Number: 867030. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0859-2026 |
IntelliVue Multi Measurement Server X2. Product Number: M3002A. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0858-2026 |
IntelliVue MP90. Product Number: M8010A. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0857-2026 |
IntelliVue MP80. Product Number: M8008A. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0856-2026 |
IntelliVue MP70. Product Number: M8007A. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0855-2026 |
IntelliVue MP60. Product Number: M8005A. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0854-2026 |
IntelliVue MP50. Product Number: M8004A. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0853-2026 |
IntelliVue MP40. Product Number: M8003A. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0852-2026 |
IntelliVue MP30. Product Number: M8002A. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0851-2026 |
IntelliVue MP20. Product Number: M8001A. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0850-2026 |
IntelliVue MP5. Product Number: M8105A. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0849-2026 |
IntelliVue MP2. Product Number: M8102A. |
— |
Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-29 |
Class II
|
Ongoing |
Z-0882-2026 |
CT 5300; Software Version Number: 4.5, 5.0, 5.1; |
— |
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with ot… |
| 2025-10-29 |
Class II
|
Ongoing |
Z-0881-2026 |
Incisive CT; Software Version Number: 4.5, 5.0, 5.1; |
— |
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with ot… |
| 2025-10-27 |
Class II
|
Ongoing |
Z-0597-2026 |
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM |
— |
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD space… |
| 2025-09-12 |
Class II
|
Ongoing |
Z-0166-2026 |
Cardiac Workstation 7000; Model Number: 860441; |
— |
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. |
| 2025-09-12 |
Class II
|
Ongoing |
Z-0165-2026 |
Cardiac Workstation 5000; Model Number: 860439; |
— |
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. |
| 2025-08-13 |
Class II
|
Ongoing |
Z-2604-2025 |
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307. |
— |
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| 2025-08-13 |
Class II
|
Ongoing |
Z-2603-2025 |
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325. |
— |
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| 2025-08-13 |
Class II
|
Ongoing |
Z-2602-2025 |
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324. |
— |
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| 2025-08-13 |
Class II
|
Ongoing |
Z-2601-2025 |
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332. |
— |
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| 2025-08-13 |
Class II
|
Ongoing |
Z-2600-2025 |
Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326… |
— |
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| 2025-08-13 |
Class II
|
Ongoing |
Z-2599-2025 |
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311. |
— |
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| 2025-08-13 |
Class II
|
Ongoing |
Z-2598-2025 |
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306. |
— |
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| 2025-08-13 |
Class II
|
Ongoing |
Z-2597-2025 |
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Onco… |
— |
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| 2025-08-13 |
Class II
|
Ongoing |
Z-2596-2025 |
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Sl… |
— |
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| 2025-08-13 |
Class II
|
Ongoing |
Z-2595-2025 |
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT … |
— |
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2218-2025 |
Upgrade to MR 7700 Model Number (REF): 782130; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2217-2025 |
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2216-2025 |
SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2215-2025 |
SmartPath to dStream for 3.0T Model Number (REF): 782145; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2214-2025 |
MR 7700 Model Numbers (REF): (1) 782120, (2) 782153; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2213-2025 |
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2212-2025 |
Intera 3.0T Quasar Dual Model Number (REF): 781150; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2211-2025 |
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY); |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2210-2025 |
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY); |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2209-2025 |
Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2208-2025 |
Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2207-2025 |
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2206-2025 |
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2205-2025 |
Ingenia 1.5T S Model Number (REF): 781347; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2204-2025 |
Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2203-2025 |
Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2202-2025 |
Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2201-2025 |
Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2200-2025 |
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345; |
— |
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. |
| 2025-05-29 |
Class II
|
Ongoing |
Z-2034-2025 |
Spectral CT. Computed tomography X-ray system. |
— |
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, al… |
| 2025-05-29 |
Class II
|
Ongoing |
Z-1936-2025 |
SmartPath to dStream for 1.5T¿; Product Number: 782146; |
— |
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to p… |
| 2025-05-29 |
Class II
|
Ongoing |
Z-1935-2025 |
Intera Achieva 1.5T Pulsar; Product Number: 781171; |
— |
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to p… |
| 2025-05-29 |
Class II
|
Ongoing |
Z-1934-2025 |
Intera 1.5T Omni/Stellar; Product Number: 781104; |
— |
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to p… |
| 2025-05-29 |
Class II
|
Ongoing |
Z-1933-2025 |
Intera 1.5T Master/Nova Product Number: 781106; |
— |
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to p… |
| 2025-05-29 |
Class II
|
Ongoing |
Z-1932-2025 |
Intera 1.5T Explorer/Nova Dual Product Number: 781108; |
— |
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to p… |
| 2025-05-29 |
Class II
|
Ongoing |
Z-1931-2025 |
Intera 1.5T Achieva Nova-Dual Product Number: 781173; |
— |
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to p… |
| 2025-05-29 |
Class II
|
Ongoing |
Z-1930-2025 |
Intera 1.5T Achieva Nova Product Number: 781172; |
— |
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to p… |
| 2025-05-29 |
Class II
|
Ongoing |
Z-1929-2025 |
Intera 1.5T Achieva IT Nova Product Number: 781175 |
— |
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to p… |
| 2025-05-29 |
Class II
|
Ongoing |
Z-1928-2025 |
Achieva XR Product Numbers: (1) 781153, (2) 781253; |
— |
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to p… |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1805-2025 |
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1804-2025 |
Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1803-2025 |
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1802-2025 |
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1801-2025 |
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1800-2025 |
Product Name: Ingenia 3.0T CX; Model Number: 781271; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1799-2025 |
Product Name: Ingenia 1.5T CX; Model Number: 781262; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1798-2025 |
Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1797-2025 |
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1796-2025 |
Product Name: Ingenia 1.5T S; Model Number: 781347; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1795-2025 |
Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1794-2025 |
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1793-2025 |
Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1792-2025 |
Product Name: Upgrade to MR 7700; Model Number: 782130; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1791-2025 |
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1790-2025 |
Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113; |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1789-2025 |
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145 |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-05-13 |
Class II
|
Ongoing |
Z-1788-2025 |
Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146 |
— |
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| 2025-04-07 |
Class II
|
Ongoing |
Z-1722-2025 |
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub… |
— |
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible. |
| 2025-04-01 |
Class II
|
Ongoing |
Z-1660-2025 |
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System. |
— |
Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient. |
| 2025-03-10 |
Class II
|
Ongoing |
Z-1554-2025 |
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System. |
— |
Potential for collimator to fall as a result of incorrect installation. |
| 2025-03-10 |
Class II
|
Ongoing |
Z-1553-2025 |
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. |
— |
Potential for collimator to fall as a result of incorrect installation. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1582-2025 |
Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic,… |
— |
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1581-2025 |
Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, in… |
— |
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1580-2025 |
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, i… |
— |
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation. |
| 2025-01-15 |
Class II
|
Ongoing |
Z-1110-2025 |
IntelliVue Patient Monitor MX550. Model Number: 866066 |
— |
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O… |
| 2025-01-15 |
Class II
|
Ongoing |
Z-1109-2025 |
IntelliVue Patient Monitor MX500. Model Number: 866064 |
— |
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O… |
| 2025-01-15 |
Class II
|
Ongoing |
Z-1108-2025 |
IntelliVue Patient Monitor MX450. Model Number: 866062 |
— |
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O… |
| 2025-01-15 |
Class II
|
Ongoing |
Z-1107-2025 |
IntelliVue Patient Monitor MX400. Model Number: 866060 |
— |
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O… |
| 2025-01-15 |
Class II
|
Ongoing |
Z-1106-2025 |
IntelliBridge EC10 Module. Model Number: 865115 |
— |
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O… |
| 2024-11-20 |
Class II
|
Ongoing |
Z-0686-2025 |
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216 |
— |
The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another… |
| 2024-11-16 |
Class II
|
Ongoing |
Z-0583-2025 |
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344. |
— |
Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle pl… |
| 2024-11-04 |
Class II
|
Ongoing |
Z-0548-2025 |
ST SENSE Breast Dx Coil |
— |
Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 |
Class II
|
Ongoing |
Z-0547-2025 |
ST SENSE Breast Coil |
— |
Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 |
Class II
|
Ongoing |
Z-0546-2025 |
SENSE Breast Coil 3.0T 7ch |
— |
Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 |
Class II
|
Ongoing |
Z-0545-2025 |
SENSE Breast Coil |
— |
Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 |
Class II
|
Ongoing |
Z-0544-2025 |
Mammotrak Interventional Coil 3.0T |
— |
Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 |
Class II
|
Ongoing |
Z-0543-2025 |
Mammotrak Diagnostic Coil 3.0T |
— |
Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 |
Class II
|
Ongoing |
Z-0542-2025 |
Mammotrak Interventional Coil 1.5T |
— |
Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 |
Class II
|
Ongoing |
Z-0541-2025 |
Mammotrak Diagnostic Coil 1.5T |
— |
Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 |
Class II
|
Ongoing |
Z-0540-2025 |
dS Breast 7ch 3.0T |
— |
Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 |
Class II
|
Ongoing |
Z-0539-2025 |
dS Breast 7ch 1.5T |
— |
Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 |
Class II
|
Ongoing |
Z-0538-2025 |
dS Breast 16ch 3.0T |
— |
Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 |
Class II
|
Ongoing |
Z-0537-2025 |
dS Breast 16ch 1.5T |
— |
Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 |
Class II
|
Ongoing |
Z-0536-2025 |
Achieva TX Interventional Coil 3.0T |
— |
Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-09-03 |
Class II
|
Ongoing |
Z-3205-2024 |
SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images a… |
— |
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving pa… |
| 2024-09-03 |
Class II
|
Ongoing |
Z-3204-2024 |
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic im… |
— |
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving pa… |
| 2024-09-03 |
Class II
|
Ongoing |
Z-3203-2024 |
SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images an… |
— |
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving pa… |
| 2024-09-03 |
Class II
|
Ongoing |
Z-3202-2024 |
MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the in… |
— |
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving pa… |
| 2024-09-03 |
Class II
|
Ongoing |
Z-3201-2024 |
MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the in… |
— |
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving pa… |
| 2024-09-03 |
Class II
|
Ongoing |
Z-3200-2024 |
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra … |
— |
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving pa… |
| 2024-09-03 |
Class II
|
Ongoing |
Z-3199-2024 |
Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra … |
— |
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving pa… |
| 2024-09-03 |
Class II
|
Ongoing |
Z-3198-2024 |
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectr… |
— |
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving pa… |
| 2024-09-03 |
Class II
|
Ongoing |
Z-3197-2024 |
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectr… |
— |
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving pa… |
| 2024-09-03 |
Class II
|
Ongoing |
Z-3196-2024 |
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra o… |
— |
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving pa… |
| 2024-09-03 |
Class II
|
Ongoing |
Z-3195-2024 |
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of t… |
— |
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving pa… |
| 2024-09-03 |
Class II
|
Ongoing |
Z-3194-2024 |
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of th… |
— |
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving pa… |
| 2024-09-03 |
Class II
|
Ongoing |
Z-3193-2024 |
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or sp… |
— |
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving pa… |
| 2024-08-30 |
Class II
|
Ongoing |
Z-3249-2024 |
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 … |
— |
During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equip… |
| 2024-06-28 |
Class II
|
Ongoing |
Z-2511-2024 |
IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicate… |
— |
Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming s… |
| 2024-06-28 |
Class II
|
Ongoing |
Z-2510-2024 |
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicate… |
— |
Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming s… |
| 2024-06-28 |
Class II
|
Ongoing |
Z-2509-2024 |
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicat… |
— |
Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming s… |
| 2024-06-28 |
Class II
|
Ongoing |
Z-2508-2024 |
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicate… |
— |
Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming s… |
| 2024-06-05 |
Class I
|
Ongoing |
Z-2165-2024 |
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achiev… |
— |
Potential for coils to heat up and harm patients (burn). |
| 2024-06-05 |
Class I
|
Ongoing |
Z-2164-2024 |
SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Sy… |
— |
Potential for coils to heat up and harm patients (burn). |
| 2024-06-05 |
Class I
|
Ongoing |
Z-2163-2024 |
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Sy… |
— |
Potential for coils to heat up and harm patients (burn). |
| 2024-05-22 |
Class II
|
Ongoing |
Z-2239-2024 |
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal he… |
— |
Potential for inaccurate fetal heart rate measurements when monitoring multiples. |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1950-2024 |
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Pro… |
— |
Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1949-2024 |
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Produc… |
— |
Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1948-2024 |
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Produc… |
— |
Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1865-2024 |
Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic devic… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1864-2024 |
Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosti… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1863-2024 |
SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a d… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1862-2024 |
SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use a… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1861-2024 |
SmartPath to dStream for 3.0T Model Number (REF): 782145 |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1860-2024 |
SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a dia… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1859-2024 |
MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1858-2024 |
MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model … |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1857-2024 |
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1856-2024 |
Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. … |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1855-2024 |
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. … |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1854-2024 |
MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Mode… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1853-2024 |
Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. M… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1852-2024 |
Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic dev… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1851-2024 |
Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic dev… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1850-2024 |
Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359 |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1849-2024 |
Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271 |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1848-2024 |
Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. … |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1847-2024 |
Ingenia 1.5T S Model Number (REF): 781347 |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1846-2024 |
Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic devi… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1845-2024 |
Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315 |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1844-2024 |
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143 |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1843-2024 |
Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosti… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1842-2024 |
AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Mode… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1841-2024 |
Achieva 3.0T TX for PET Model Number (REF): 781479 |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1840-2024 |
Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic d… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1839-2024 |
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177 |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1838-2024 |
Achieva 1.5T Initial system Model Number (REF): 781178 |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1837-2024 |
Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosti… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-05-03 |
Class II
|
Ongoing |
Z-1836-2024 |
Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device M… |
— |
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's tech… |
| 2024-04-22 |
Class II
|
Ongoing |
Z-1830-2024 |
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated fo… |
— |
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or bur… |
| 2024-04-22 |
Class II
|
Ongoing |
Z-1829-2024 |
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for … |
— |
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or bur… |
| 2024-04-19 |
Class II
|
Ongoing |
Z-1827-2024 |
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x. |
— |
Event Catalog information does not save when copied and transferred from one unit to another. |
| 2024-04-15 |
Class II
|
Ongoing |
Z-1872-2024 |
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728… |
— |
Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential cont… |
| 2024-04-15 |
Class II
|
Ongoing |
Z-1871-2024 |
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728… |
— |
Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential cont… |
| 2024-03-29 |
Class II
|
Ongoing |
Z-1756-2024 |
The Oncology Essentials Package of the Spectral CT imaging system. |
— |
Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorre… |
| 2024-03-22 |
Class II
|
Ongoing |
Z-1690-2024 |
Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporati… |
— |
Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX sy… |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1590-2024 |
SmartPath to dStream for XR and 3.0T, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1589-2024 |
SmartPath to dStream for 1.5T, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1588-2024 |
MR 7700, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1587-2024 |
MR 5300, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1586-2024 |
Intera CV, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1585-2024 |
Intera Achieva 1.5T Pulsar, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1584-2024 |
Intera 3.0T Quasar Dual, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1583-2024 |
Intera 1.5T R11, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1582-2024 |
Intera 1.5T Power/Pulsar, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1581-2024 |
Intera 1.5T Omni/Stellar, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1580-2024 |
Intera 1.5T Master/Nova, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1579-2024 |
Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1578-2024 |
Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1577-2024 |
Intera 1.5T Achieva Nova, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1576-2024 |
Intera 1.5T Achieva IT Nova, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1575-2024 |
Intera 1.5T, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1574-2024 |
Intera 1.0T Power/Pulsar, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1573-2024 |
Intera 1.0T Omni/Stellar, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1572-2024 |
Intera 0.5T Standard, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1571-2024 |
Ingenia Elition X, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1570-2024 |
Ingenia Elition S, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1569-2024 |
Ingenia Ambition X, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1568-2024 |
Ingenia Ambition S, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1567-2024 |
Ingenia 3.0T CX, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1566-2024 |
Ingenia 3.0T, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1565-2024 |
Ingenia 1.5T S, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1564-2024 |
Ingenia 1.5T CX, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1563-2024 |
Ingenia 1.5T, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1562-2024 |
GYROSCAN T5-NT, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1561-2024 |
GYROSCAN T5, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1560-2024 |
GYROSCAN T10-NT, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1559-2024 |
GYROSCAN ACS-NT, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1558-2024 |
Evolution Upgrade 3.0T, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1557-2024 |
Enterprise 1.5T, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1556-2024 |
Achieva XR, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1555-2024 |
Achieva 3.0TX for PET, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1554-2024 |
Achieva 3.0T for PET, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1553-2024 |
Achieva 3.0T, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1552-2024 |
Achieva 1.5T Initial, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1551-2024 |
Achieva 1.5T Conversion, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-03-12 |
Class II
|
Ongoing |
Z-1550-2024 |
Achieva 1.5T, Magnetic Resonance System. |
— |
Patient support table floor plate may be incorrectly installed. |
| 2024-02-28 |
Class II
|
Ongoing |
Z-1387-2024 |
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X |
— |
It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a pass… |
| 2024-02-28 |
Class II
|
Ongoing |
Z-1386-2024 |
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) runni… |
— |
It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a pass… |
| 2024-02-15 |
Class II
|
Ongoing |
Z-3312-2024 |
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD… |
— |
If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a po… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-0956-2024 |
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129. |
— |
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the sca… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-0955-2024 |
SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112. |
— |
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the sca… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-0954-2024 |
Intera Achieva 1.5T Pulsar. Model (REF) Number 781171. |
— |
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the sca… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-0953-2024 |
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173. |
— |
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the sca… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-0952-2024 |
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172. |
— |
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the sca… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-0951-2024 |
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105. |
— |
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the sca… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-0950-2024 |
Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261. |
— |
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the sca… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-0949-2024 |
Achieva XR. Model (REF) Numbers 781153, 781253. |
— |
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the sca… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-0948-2024 |
Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345. |
— |
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the sca… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-0947-2024 |
Achieva 1.5T Initial system. Model (REF) Numbers 781178. |
— |
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the sca… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-0946-2024 |
Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283. |
— |
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the sca… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-0945-2024 |
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296. |
— |
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the sca… |
| 2023-12-29 |
Class III
|
Ongoing |
Z-0812-2024 |
SmartPath to dStream for 1.5T, Model No. 781260, 782112 |
— |
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect… |
| 2023-12-29 |
Class III
|
Ongoing |
Z-0811-2024 |
Intera 1.5T, Model No. 781195 |
— |
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect… |
| 2023-12-29 |
Class III
|
Ongoing |
Z-0810-2024 |
Ingenia Ambition X, Model No. 782109 |
— |
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect… |
| 2023-12-29 |
Class III
|
Ongoing |
Z-0809-2024 |
Achieva 3.0T, Model No. 781177 |
— |
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect… |
| 2023-12-29 |
Class III
|
Ongoing |
Z-0808-2024 |
Achieva 1.5T Conversion, Model No. 781283 |
— |
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect… |
| 2023-12-29 |
Class III
|
Ongoing |
Z-0807-2024 |
Achieva 1.5T, Model No. 781178, 781196, 781296 |
— |
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect… |
| 2023-12-15 |
Class II
|
Ongoing |
Z-1073-2024 |
ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150 |
— |
Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while… |
| 2023-12-15 |
Class II
|
Ongoing |
Z-1072-2024 |
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110 |
— |
Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient scan whil… |
| 2023-12-15 |
Class I
|
Ongoing |
Z-0931-2024 |
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 45356074… |
— |
Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, l… |
| 2023-12-15 |
Class I
|
Ongoing |
Z-0930-2024 |
BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 4535608292… |
— |
Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, l… |
| 2023-12-15 |
Class I
|
Ongoing |
Z-0929-2024 |
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 4… |
— |
Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, l… |
| 2023-12-07 |
Class II
|
Ongoing |
Z-0719-2024 |
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871 |
— |
If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding … |
| 2023-11-30 |
Class II
|
Ongoing |
Z-0725-2024 |
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. |
— |
Multiple software issues that affect device functionality. |
| 2023-11-30 |
Class II
|
Ongoing |
Z-0679-2024 |
BrightView XCT, Gamma Camera, Product Code 882482 |
— |
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a… |
| 2023-11-30 |
Class II
|
Ongoing |
Z-0678-2024 |
BrightView X, Gamma Camera, Product Code 882478 |
— |
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a… |
| 2023-11-30 |
Class II
|
Ongoing |
Z-0677-2024 |
BrightView, Gamma Camera System, Product Code 882480. |
— |
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a… |
| 2023-11-28 |
Class II
|
Ongoing |
Z-0732-2024 |
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436 |
— |
Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in… |
| 2023-11-28 |
Class II
|
Ongoing |
Z-0731-2024 |
(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC… |
— |
Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in… |
| 2023-11-17 |
Class I
|
Ongoing |
Z-0505-2024 |
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) syst… |
— |
Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas du… |
| 2023-10-23 |
Class II
|
Ongoing |
Z-0395-2024 |
SmartPath to dStream for 1.5T |
— |
Potential component failure in the Gradient Coil could product smoke and/or fire. |
| 2023-10-23 |
Class II
|
Ongoing |
Z-0394-2024 |
Intera 1.5T Power/Pulsar |
— |
Potential component failure in the Gradient Coil could product smoke and/or fire. |
| 2023-10-23 |
Class II
|
Ongoing |
Z-0393-2024 |
Intera 1.5T |
— |
Potential component failure in the Gradient Coil could product smoke and/or fire. |
| 2023-10-23 |
Class II
|
Ongoing |
Z-0392-2024 |
Ingenia 1.5T CX |
— |
Potential component failure in the Gradient Coil could product smoke and/or fire. |
| 2023-10-23 |
Class II
|
Ongoing |
Z-0391-2024 |
Achieva 1.5T Initial System |
— |
Potential component failure in the Gradient Coil could product smoke and/or fire. |
| 2023-10-23 |
Class II
|
Ongoing |
Z-0390-2024 |
Achieva 1.5T Conversion |
— |
Potential component failure in the Gradient Coil could product smoke and/or fire. |
| 2023-10-23 |
Class II
|
Ongoing |
Z-0389-2024 |
Achieva 1.5T |
— |
Potential component failure in the Gradient Coil could product smoke and/or fire. |
| 2023-10-09 |
Class II
|
Ongoing |
Z-0319-2024 |
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 |
— |
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the pla… |
| 2023-10-09 |
Class II
|
Ongoing |
Z-0306-2024 |
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 |
— |
When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the… |
| 2023-10-09 |
Class II
|
Ongoing |
Z-0294-2024 |
Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed fo… |
— |
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary imag… |
| 2023-10-09 |
Class II
|
Ongoing |
Z-0293-2024 |
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiati… |
— |
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary imag… |
| 2023-10-09 |
Class II
|
Ongoing |
Z-0292-2024 |
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncolo… |
— |
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary imag… |
| 2023-10-04 |
Class II
|
Ongoing |
Z-0230-2024 |
Veradius Unity Mobile Surgery C-arm |
— |
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning… |
| 2023-10-04 |
Class II
|
Ongoing |
Z-0229-2024 |
Azurion IGTS Fixed Systems |
— |
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning… |
| 2023-10-04 |
Class II
|
Ongoing |
Z-0228-2024 |
Allura Xper IGTS Fixed Systems |
— |
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning… |
| 2023-10-04 |
Class II
|
Ongoing |
Z-0227-2024 |
Integris-Allura IGTS Fixed Systems |
— |
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning… |
| 2023-10-04 |
Class II
|
Ongoing |
Z-0226-2024 |
Zenition 50 & 70 Mobile Surgery C-arm |
— |
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning… |
| 2023-10-04 |
Class II
|
Ongoing |
Z-0224-2024 |
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems. |
— |
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning… |
| 2023-09-21 |
Class II
|
Ongoing |
Z-0280-2024 |
ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system |
— |
Potential for units suspended on the ceiling to fail and fall. |
| 2023-09-21 |
Class II
|
Ongoing |
Z-0279-2024 |
EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images. |
— |
Potential for units suspended on the ceiling to fail and fall. |
| 2023-09-21 |
Class II
|
Ongoing |
Z-0278-2024 |
DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images. |
— |
Potential for units suspended on the ceiling to fail and fall. |
| 2023-09-21 |
Class II
|
Ongoing |
Z-0277-2024 |
DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images. |
— |
Potential for units suspended on the ceiling to fail and fall. |
| 2023-09-21 |
Class II
|
Ongoing |
Z-0276-2024 |
DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images. |
— |
Potential for units suspended on the ceiling to fail and fall. |
| 2023-09-21 |
Class II
|
Ongoing |
Z-0275-2024 |
DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images… |
— |
Potential for units suspended on the ceiling to fail and fall. |
| 2023-09-21 |
Class II
|
Ongoing |
Z-0274-2024 |
DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images. |
— |
Potential for units suspended on the ceiling to fail and fall. |
| 2023-09-21 |
Class II
|
Ongoing |
Z-0273-2024 |
DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images. |
— |
Potential for units suspended on the ceiling to fail and fall. |
| 2023-09-21 |
Class II
|
Ongoing |
Z-0272-2024 |
DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images. |
— |
Potential for units suspended on the ceiling to fail and fall. |
| 2023-09-21 |
Class II
|
Ongoing |
Z-0271-2024 |
CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system |
— |
Potential for units suspended on the ceiling to fail and fall. |
| 2023-08-31 |
Class II
|
Ongoing |
Z-2655-2023 |
EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) si… |
— |
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated. |
| 2023-08-31 |
Class II
|
Ongoing |
Z-2654-2023 |
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultan… |
— |
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated. |
| 2023-08-17 |
Class II
|
Ongoing |
Z-2608-2023 |
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Pr… |
— |
Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual… |
| 2023-06-14 |
Class II
|
Ongoing |
Z-0020-2025 |
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affecte… |
— |
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities pr… |
| 2023-06-12 |
Class II
|
Ongoing |
Z-2400-2023 |
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) |
— |
During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installe… |
| 2023-06-12 |
Class II
|
Ongoing |
Z-2399-2023 |
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 |
— |
During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installe… |
| 2023-06-12 |
Class II
|
Ongoing |
Z-2398-2023 |
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Eliti… |
— |
During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installe… |
| 2023-06-12 |
Class II
|
Ongoing |
Z-2397-2023 |
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) |
— |
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system. |
| 2023-06-12 |
Class II
|
Ongoing |
Z-2396-2023 |
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 |
— |
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system. |
| 2023-06-12 |
Class II
|
Ongoing |
Z-2395-2023 |
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Eliti… |
— |
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system. |
| 2023-05-19 |
Class II
|
Ongoing |
Z-2042-2023 |
DigitalDiagnost C90, Model No. 712034 and 712035 |
— |
There is a software login in issue that may prevent the user from logging in. |
| 2023-04-25 |
Class II
|
Ongoing |
Z-2261-2023 |
Incisive CT Plus-Computed Tomography X-Ray System Model: 728149 |
— |
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other … |
| 2023-04-25 |
Class II
|
Ongoing |
Z-2260-2023 |
Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148 |
— |
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other … |
| 2023-04-25 |
Class II
|
Ongoing |
Z-2259-2023 |
Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146 |
— |
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other … |
| 2023-04-25 |
Class II
|
Ongoing |
Z-2258-2023 |
Incisive CT-Computed Tomography X-Ray System Model: 728143 |
— |
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other … |
| 2023-04-19 |
Class II
|
Ongoing |
Z-0035-2025 |
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Softw… |
— |
During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires wh… |
| 2023-03-20 |
Class II
|
Ongoing |
Z-1586-2023 |
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813 |
— |
Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the … |
| 2023-03-20 |
Class II
|
Ongoing |
Z-1585-2023 |
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814 |
— |
Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the … |
| 2023-03-17 |
Class II
|
Ongoing |
Z-1584-2023 |
Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333 |
— |
Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while … |
| 2023-03-09 |
Class II
|
Ongoing |
Z-1383-2023 |
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204 |
— |
If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of… |
| 2023-03-09 |
Class II
|
Ongoing |
Z-1382-2023 |
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201 |
— |
If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of… |
| 2023-03-06 |
Class II
|
Ongoing |
Z-1645-2023 |
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380 |
— |
EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failur… |
| 2023-03-06 |
Class II
|
Ongoing |
Z-1644-2023 |
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359 |
— |
EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failur… |
| 2023-03-03 |
Class II
|
Ongoing |
Z-1589-2023 |
CombiDiagnost R90 R1.1 |
— |
Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification … |
| 2023-03-03 |
Class II
|
Ongoing |
Z-1588-2023 |
CombiDiagnost R90 R.1.0 |
— |
Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification … |
| 2023-03-03 |
Class II
|
Ongoing |
Z-1587-2023 |
ProxiDiagnost N90 R.1.0 |
— |
Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification … |
| 2023-01-18 |
Class II
|
Ongoing |
Z-0007-2025 |
IntelliVue G7m Anesthesia Gas Module, Product Number 866173 |
— |
The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G… |
| 2022-11-22 |
Class II
|
Ongoing |
Z-0463-2023 |
Philips Upgrade to MR 7700 System, Model Number 782130 |
— |
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. |
| 2022-11-22 |
Class II
|
Ongoing |
Z-0462-2023 |
Philips MR 7700 System, Model Number 782120 |
— |
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. |
| 2022-11-22 |
Class II
|
Ongoing |
Z-0461-2023 |
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144 |
— |
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. |
| 2022-11-22 |
Class II
|
Ongoing |
Z-0460-2023 |
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136 |
— |
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. |
| 2022-11-22 |
Class II
|
Ongoing |
Z-0459-2023 |
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 |
— |
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. |
| 2022-11-21 |
Class II
|
Ongoing |
Z-0908-2023 |
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 9898031376… |
— |
Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient… |
| 2022-10-21 |
Class II
|
Ongoing |
Z-1477-2023 |
Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radio… |
— |
Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sl… |
| 2022-09-06 |
Class II
|
Ongoing |
Z-0004-2023 |
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162. |
— |
Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not rel… |
| 2022-03-29 |
Class II
|
Completed |
Z-0576-2024 |
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross… |
— |
Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/funct… |
| 2022-02-25 |
Class II
|
Ongoing |
Z-1563-2022 |
DigitalDiagnost C50 1.1 |
— |
Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation… |
| 2022-02-22 |
Class II
|
Terminated |
Z-1041-2022 |
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and… |
— |
When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the … |
| 2022-02-07 |
Class II
|
Ongoing |
Z-0926-2022 |
The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following produ… |
— |
Update to instructions for use regarding the cleaning and disinfection process for the reusable probes. |
| 2022-02-04 |
Class II
|
Ongoing |
Z-0882-2022 |
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, … |
— |
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resul… |
| 2022-02-04 |
Class II
|
Ongoing |
Z-0881-2022 |
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS |
— |
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resul… |
| 2022-02-02 |
Class II
|
Ongoing |
Z-0874-2022 |
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers… |
— |
Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous r… |
| 2022-01-06 |
Class II
|
Ongoing |
Z-0975-2024 |
Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation syst… |
— |
Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field. |
| 2022-01-06 |
Class II
|
Ongoing |
Z-0974-2024 |
Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation syste… |
— |
Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field. |
| 2022-01-06 |
Class II
|
Ongoing |
Z-0973-2024 |
Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system |
— |
Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field. |
| 2022-01-03 |
Class II
|
Terminated |
Z-0549-2022 |
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareMan… |
— |
eCareManager (eCM) Sentry Score software not approved for use |
| 2021-11-29 |
Class II
|
Ongoing |
Z-0509-2022 |
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 |
— |
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modifie… |
| 2021-11-29 |
Class II
|
Ongoing |
Z-0508-2022 |
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T |
— |
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modifie… |
| 2021-11-29 |
Class II
|
Ongoing |
Z-0507-2022 |
Heel Snuggler, Reference # 989805603411 99047 |
— |
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modifie… |
| 2021-11-29 |
Class II
|
Ongoing |
Z-0506-2022 |
Infant Heel Warmers w/strap, Reference # 989805603201 1223 |
— |
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modifi… |
| 2021-11-26 |
Class II
|
Ongoing |
Z-0505-2022 |
Infa-Therm Transport Mattress, Reference Number 989805616831 1015 |
— |
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modifie… |
| 2021-11-24 |
Class II
|
Ongoing |
Z-0725-2022 |
Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray… |
— |
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical c… |
| 2021-11-24 |
Class II
|
Ongoing |
Z-0724-2022 |
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chil… |
— |
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical c… |
| 2021-11-19 |
Class II
|
Terminated |
Z-0416-2022 |
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascul… |
— |
Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the … |
| 2021-11-12 |
Class II
|
Terminated |
Z-0471-2022 |
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurio… |
— |
(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; … |
| 2021-11-12 |
Class II
|
Ongoing |
Z-0357-2022 |
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132 |
— |
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image… |
| 2021-11-12 |
Class II
|
Ongoing |
Z-0356-2022 |
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718… |
— |
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image… |
| 2021-11-12 |
Class II
|
Ongoing |
Z-0355-2022 |
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718… |
— |
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image… |
| 2021-10-29 |
Class II
|
Ongoing |
Z-0476-2022 |
Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . … |
— |
Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure |
| 2021-10-21 |
Class II
|
Ongoing |
Z-1356-2023 |
ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110 |
— |
If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may exper… |
| 2021-10-21 |
Class II
|
Ongoing |
Z-1355-2023 |
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031 |
— |
If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may exper… |
| 2021-09-24 |
Class II
|
Terminated |
Z-0213-2022 |
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, … |
— |
When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movem… |
| 2021-08-13 |
Class II
|
Terminated |
Z-2476-2021 |
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidanc… |
— |
Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of th… |
| 2021-08-13 |
Class II
|
Terminated |
Z-2475-2021 |
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular im… |
— |
Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of th… |
| 2021-08-13 |
Class II
|
Terminated |
Z-2474-2021 |
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular ima… |
— |
Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of th… |
| 2021-08-11 |
Class II
|
Completed |
Z-2422-2021 |
Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system c… |
— |
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in … |
| 2021-08-11 |
Class II
|
Completed |
Z-2421-2021 |
SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic d… |
— |
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in … |
| 2021-08-11 |
Class II
|
Completed |
Z-2420-2021 |
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can… |
— |
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in … |
| 2021-08-11 |
Class II
|
Completed |
Z-2419-2021 |
Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system c… |
— |
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in … |
| 2021-08-11 |
Class II
|
Completed |
Z-2418-2021 |
Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system c… |
— |
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in … |
| 2021-08-11 |
Class II
|
Completed |
Z-2417-2021 |
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can pr… |
— |
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in … |
| 2021-08-11 |
Class II
|
Completed |
Z-2416-2021 |
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system … |
— |
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in … |
| 2021-08-11 |
Class II
|
Completed |
Z-2415-2021 |
SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. … |
— |
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in … |
| 2021-08-11 |
Class II
|
Completed |
Z-2414-2021 |
Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can… |
— |
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in … |
| 2021-08-11 |
Class II
|
Completed |
Z-2413-2021 |
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can … |
— |
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in … |
| 2021-08-11 |
Class II
|
Completed |
Z-2412-2021 |
Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The sys… |
— |
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in … |
| 2021-08-11 |
Class II
|
Completed |
Z-2411-2021 |
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can p… |
— |
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in … |
| 2021-07-30 |
Class II
|
Terminated |
Z-2347-2021 |
Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system ca… |
— |
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury |
| 2021-07-30 |
Class II
|
Terminated |
Z-2346-2021 |
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can pro… |
— |
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury |
| 2021-07-30 |
Class II
|
Terminated |
Z-2345-2021 |
Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can … |
— |
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury |
| 2021-07-30 |
Class II
|
Terminated |
Z-2344-2021 |
Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system ca… |
— |
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury |
| 2021-07-30 |
Class II
|
Terminated |
Z-2343-2021 |
Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can pro… |
— |
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury |
| 2021-07-30 |
Class II
|
Terminated |
Z-2342-2021 |
Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can pro… |
— |
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury |
| 2021-07-30 |
Class II
|
Terminated |
Z-2341-2021 |
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The syste… |
— |
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury |
| 2021-07-16 |
Class II
|
Terminated |
Z-2427-2021 |
Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE… |
— |
Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patie… |
| 2021-07-15 |
Class II
|
Ongoing |
Z-0715-2024 |
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359) |
— |
The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.) |
| 2021-06-08 |
Class II
|
Terminated |
Z-2318-2021 |
728333 Spectral CT 7500 -Computed Tomography X-ray system |
— |
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, result… |
| 2021-06-08 |
Class II
|
Terminated |
Z-2317-2021 |
728332 IQon Spectral CT-Computed Tomography X-ray system |
— |
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, result… |
| 2021-06-08 |
Class II
|
Terminated |
Z-2316-2021 |
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system |
— |
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, result… |
| 2021-06-08 |
Class II
|
Terminated |
Z-2315-2021 |
Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system |
— |
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, result… |
| 2021-06-08 |
Class II
|
Terminated |
Z-2314-2021 |
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades |
— |
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, result… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-1990-2021 |
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brillia… |
— |
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension A… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-1989-2021 |
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT |
— |
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension A… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-1988-2021 |
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT |
— |
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension A… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-1987-2021 |
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT |
— |
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension A… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-1986-2021 |
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT: |
— |
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension A… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-1985-2021 |
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spect… |
— |
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension A… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-1984-2021 |
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenui… |
— |
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension A… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-1983-2021 |
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT s… |
— |
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension A… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-1982-2021 |
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT s… |
— |
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension A… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-1981-2021 |
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT s… |
— |
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension A… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-1980-2021 |
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Mo… |
— |
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension A… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-1979-2021 |
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT s… |
— |
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension A… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-0281-2022 |
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (C… |
— |
Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and res… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-0280-2022 |
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT … |
— |
Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and res… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-0279-2022 |
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Con… |
— |
Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and res… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-0278-2022 |
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continu… |
— |
Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and res… |
| 2021-05-01 |
Class II
|
Ongoing |
Z-0277-2022 |
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous… |
— |
Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and res… |
| 2021-04-23 |
Class II
|
Ongoing |
Z-1796-2021 |
Ingenia Ambition S - Model Number: 781359 Diagnostic MR system. |
— |
The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by … |
| 2021-04-23 |
Class II
|
Ongoing |
Z-1795-2021 |
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 … |
— |
The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by … |
| 2021-04-13 |
Class II
|
Terminated |
Z-1774-2021 |
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model … |
— |
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury |
| 2021-03-29 |
Class II
|
Ongoing |
Z-1517-2021 |
Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional… |
— |
Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure an… |
| 2021-03-23 |
Class II
|
Terminated |
Z-1326-2021 |
Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple … |
— |
Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the … |
| 2021-02-22 |
Class II
|
Terminated |
Z-1265-2021 |
Incisive CT Computed Tomography X-ray System Model: 728143 |
— |
Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected c… |
| 2021-02-09 |
Class II
|
Ongoing |
Z-0081-2022 |
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A |
— |
Customers were not notified of previous recalls associated with various defibrillator models. |
| 2021-02-09 |
Class II
|
Ongoing |
Z-0080-2022 |
Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A |
— |
Customers were not notified of previous recalls associated with various defibrillator models. |
| 2021-02-09 |
Class II
|
Ongoing |
Z-0079-2022 |
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304 |
— |
Customers were not notified of previous recalls associated with various defibrillator models. |
| 2021-02-09 |
Class II
|
Ongoing |
Z-0078-2022 |
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A |
— |
Customers were not notified of previous recalls associated with various defibrillator models. |
| 2021-02-02 |
Class II
|
Terminated |
Z-1671-2021 |
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage:… |
— |
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices |
| 2020-12-24 |
Class II
|
Ongoing |
Z-1507-2024 |
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intend… |
— |
Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the mo… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0852-2021 |
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging … |
— |
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient. |
| 2020-11-18 |
Class II
|
Terminated |
Z-0545-2021 |
Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to gener… |
— |
Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result i… |
| 2020-11-18 |
Class II
|
Terminated |
Z-0544-2021 |
Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording o… |
— |
Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result i… |
| 2020-09-14 |
Class II
|
Terminated |
Z-0285-2021 |
Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - … |
— |
The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Inter… |
| 2020-09-14 |
Class II
|
Terminated |
Z-0284-2021 |
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Pr… |
— |
The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Inter… |
| 2020-07-16 |
Class II
|
Terminated |
Z-2794-2020 |
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M35… |
— |
The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may … |
| 2020-06-30 |
Class II
|
Terminated |
Z-2697-2020 |
IntelliVue MX700 patient monitor, model no. 865241 |
— |
Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monito… |
| 2020-06-30 |
Class II
|
Terminated |
Z-2696-2020 |
IntelliVue MX800 patient monitor, model no. 865240 |
— |
Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monito… |
| 2020-06-25 |
Class II
|
Ongoing |
Z-2689-2020 |
IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 4535644774… |
— |
The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and generating one or more t… |
| 2020-06-18 |
Class II
|
Terminated |
Z-2812-2020 |
Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MR… |
— |
A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery i… |
| 2020-06-18 |
Class II
|
Terminated |
Z-2811-2020 |
Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR40… |
— |
A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery i… |
| 2020-06-18 |
Class II
|
Terminated |
Z-2810-2020 |
Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expr… |
— |
A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery i… |
| 2020-06-08 |
Class II
|
Terminated |
Z-2531-2020 |
Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030… |
— |
Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and lntelliVue MMX multi-measurement server (Model No. 867… |
| 2020-06-02 |
Class II
|
Terminated |
Z-2523-2020 |
EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose. |
— |
Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction. |
| 2020-05-19 |
Class II
|
Terminated |
Z-2337-2020 |
Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measu… |
— |
Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that was not intended for commercial distribution and for which Phil… |
| 2020-04-27 |
Class II
|
Terminated |
Z-2157-2020 |
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for… |
— |
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections |
| 2020-04-23 |
Class II
|
Terminated |
Z-2256-2020 |
ProxiDiagnost N90, UDI 706100 |
— |
The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution Unit, may be incorrectly installed and not… |
| 2020-04-21 |
Class II
|
Terminated |
Z-2137-2020 |
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualif… |
— |
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections |
| 2020-04-20 |
Class II
|
Terminated |
Z-2134-2020 |
Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibr… |
— |
Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine operational… |
| 2020-04-13 |
Class II
|
Terminated |
Z-2245-2020 |
Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the p… |
— |
The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2244-2020 |
Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bel… |
— |
The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2053-2020 |
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualifi… |
— |
The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the… |
| 2020-04-10 |
Class II
|
Terminated |
Z-2064-2020 |
HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/De… |
— |
Damaged ESD bags used for storing components in Processor PCA Replacement Kits |
| 2020-04-10 |
Class II
|
Terminated |
Z-1933-2020 |
Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualizatio… |
— |
When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or … |
| 2020-04-10 |
Class II
|
Terminated |
Z-1932-2020 |
Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualizatio… |
— |
When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or … |
| 2020-04-07 |
Class II
|
Terminated |
Z-1806-2020 |
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography. |
— |
If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury. |
| 2020-04-06 |
Class II
|
Terminated |
Z-1923-2020 |
Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)86006… |
— |
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems. |
| 2020-04-06 |
Class II
|
Terminated |
Z-1922-2020 |
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311 |
— |
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems. |
| 2020-04-06 |
Class II
|
Terminated |
Z-1921-2020 |
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)008848… |
— |
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems. |
| 2020-04-03 |
Class II
|
Terminated |
Z-1809-2020 |
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system … |
— |
When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before sta… |
| 2020-03-05 |
Class II
|
Terminated |
Z-1801-2020 |
Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minima… |
— |
No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becomi… |
| 2020-03-05 |
Class II
|
Terminated |
Z-1767-2020 |
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 45356400… |
— |
The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a Phi… |
| 2020-03-05 |
Class II
|
Terminated |
Z-1766-2020 |
TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 45356405… |
— |
The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a Phi… |
| 2020-02-26 |
Class II
|
Terminated |
Z-1499-2020 |
HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M35… |
— |
Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after … |
| 2020-02-20 |
Class II
|
Terminated |
Z-1616-2020 |
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.0… |
— |
Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, th… |
| 2020-01-14 |
Class II
|
Terminated |
Z-1342-2020 |
Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Produ… |
— |
M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments |
| 2020-01-13 |
Class II
|
Terminated |
Z-1345-2020 |
Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four… |
— |
if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display… |