| 2026-02-27 |
Class II
|
Ongoing |
Z-1767-2026 |
SIGNA Premier systems |
— |
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (stee… |
| 2026-01-16 |
Class II
|
Ongoing |
Z-1475-2026 |
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; … |
— |
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) w… |
| 2025-11-03 |
Class II
|
Ongoing |
Z-0935-2026 |
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system |
— |
GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medic… |
| 2025-02-19 |
Class II
|
Ongoing |
Z-1487-2025 |
GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; … |
— |
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity … |
| 2025-02-19 |
Class II
|
Ongoing |
Z-1486-2025 |
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-00… |
— |
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity … |
| 2025-02-19 |
Class II
|
Ongoing |
Z-1485-2025 |
GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; … |
— |
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity … |
| 2025-02-19 |
Class II
|
Ongoing |
Z-1484-2025 |
GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2… |
— |
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity … |
| 2025-02-19 |
Class II
|
Ongoing |
Z-1483-2025 |
GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) … |
— |
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity … |
| 2024-10-03 |
Class II
|
Ongoing |
Z-0318-2025 |
GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2… |
— |
GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security vulnerability which co… |
| 2024-08-29 |
Class II
|
Ongoing |
Z-0039-2025 |
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b… |
— |
GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown b… |
| 2024-08-08 |
Class II
|
Ongoing |
Z-3146-2024 |
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, … |
— |
The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prio… |
| 2024-08-08 |
Class II
|
Ongoing |
Z-3145-2024 |
ViewPoint; system, imaging processing, radiological |
— |
The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prio… |
| 2024-08-05 |
Class II
|
Ongoing |
Z-3214-2024 |
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system. |
— |
GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckey… |
| 2024-07-23 |
Class II
|
Ongoing |
Z-3160-2024 |
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; … |
— |
Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum i… |
| 2023-09-14 |
Class II
|
Ongoing |
Z-0140-2024 |
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System |
— |
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x… |
| 2023-09-14 |
Class II
|
Ongoing |
Z-0139-2024 |
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System |
— |
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x… |
| 2023-09-14 |
Class II
|
Ongoing |
Z-0138-2024 |
Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System |
— |
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x… |
| 2023-09-08 |
Class II
|
Ongoing |
Z-0143-2024 |
Universal Viewer Workflow Manager, Image processing radiological system |
— |
When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could… |
| 2023-09-08 |
Class II
|
Ongoing |
Z-0142-2024 |
Centricity Universal Viewer Workflow Manager, Image processing radiological system |
— |
When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could… |
| 2023-03-28 |
Class II
|
Ongoing |
Z-1502-2023 |
Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012,… |
— |
GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information. |
| 2023-03-28 |
Class II
|
Ongoing |
Z-1501-2023 |
Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026,… |
— |
GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information. |
| 2023-03-28 |
Class II
|
Ongoing |
Z-1500-2023 |
Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 206… |
— |
GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information. |
| 2022-07-15 |
Class II
|
Ongoing |
Z-1566-2022 |
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3… |
— |
Inaccurate Distance and Area measurements with use of Global Stack viewport. |
| 2022-06-24 |
Class II
|
Ongoing |
Z-1430-2022 |
SIGNA Premier magnetic resonance scanner, model 5748519. |
— |
Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise… |
| 2022-06-14 |
Class II
|
Terminated |
Z-1466-2022 |
Centricity PACS Software Version 7.0 SP0.0.4.7 |
— |
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams. |
| 2022-06-14 |
Class II
|
Terminated |
Z-1466-2022 |
Centricity PACS Software Version 7.0 SP0.0.4.7 |
— |
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams. |
| 2022-06-08 |
Class II
|
Ongoing |
Z-1333-2022 |
GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data with… |
— |
Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP) |
| 2022-06-02 |
Class II
|
Ongoing |
Z-1511-2022 |
Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Cap… |
— |
As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service pers… |
| 2022-06-01 |
Class I
|
Terminated |
Z-1389-2022 |
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia Syste… |
— |
There is a potential reversal of the O2 and air cylinder pressure transducer connections. |
| 2022-05-27 |
Class II
|
Ongoing |
Z-1427-2022 |
GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part… |
— |
The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result i… |
| 2022-05-10 |
Class II
|
Ongoing |
Z-1265-2022 |
CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU an… |
— |
The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the centr… |
| 2022-04-28 |
Class II
|
Ongoing |
Z-1233-2022 |
Centricity PACS RA1000 |
— |
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area… |
| 2022-04-28 |
Class II
|
Ongoing |
Z-1232-2022 |
Centricity Cardiology CA1000 |
— |
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area… |
| 2022-04-28 |
Class II
|
Ongoing |
Z-1231-2022 |
Centricity Radiology RA600 |
— |
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area… |
| 2022-04-28 |
Class II
|
Ongoing |
Z-1230-2022 |
Centricity Enterprise Web |
— |
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area… |
| 2022-04-28 |
Class II
|
Ongoing |
Z-1229-2022 |
Centricity Universal Viewer Zero Footprint Client |
— |
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area… |
| 2022-04-25 |
Class II
|
Ongoing |
Z-1286-2022 |
Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo… |
— |
Backup batteries can fail earlier than their estimated life. |
| 2022-04-25 |
Class II
|
Ongoing |
Z-1285-2022 |
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019 |
— |
Backup batteries can fail earlier than their estimated life. |
| 2022-04-18 |
Class I
|
Ongoing |
Z-1227-2022 |
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engst… |
— |
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply. |
| 2022-04-18 |
Class I
|
Ongoing |
Z-1226-2022 |
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116)… |
— |
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply. |
| 2022-03-16 |
Class II
|
Terminated |
Z-0919-2022 |
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008 |
— |
Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client. |
| 2022-03-04 |
Class II
|
Ongoing |
Z-0983-2022 |
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery … |
— |
During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secur… |
| 2022-02-18 |
Class II
|
Ongoing |
Z-0860-2022 |
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System |
— |
There is potential for the images to be flipped left to right. |
| 2022-02-18 |
Class II
|
Ongoing |
Z-0859-2022 |
SIGNA Excite 3T. Magnetic Resonance Imaging System |
— |
There is potential for the images to be flipped left to right. |
| 2022-02-18 |
Class II
|
Ongoing |
Z-0858-2022 |
1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System |
— |
There is potential for the images to be flipped left to right. |
| 2022-02-18 |
Class II
|
Ongoing |
Z-0857-2022 |
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System |
— |
There is potential for the images to be flipped left to right. |
| 2022-01-28 |
Class II
|
Ongoing |
Z-0808-2022 |
GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082… |
— |
If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0621-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnet… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0620-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance … |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0619-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0618-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imag… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0617-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0616-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imagin… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0615-2022 |
GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System,… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0614-2022 |
GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0613-2022 |
GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0612-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance … |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0611-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance im… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0610-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0609-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resona… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0608-2022 |
GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0607-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic reson… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0606-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0605-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR Syste… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0604-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic … |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0603-2022 |
GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0602-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic res… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0601-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuc… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0600-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance i… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0599-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition s… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0598-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance sy… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0597-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magne… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0596-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear … |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0595-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0594-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic res… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0593-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic re… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0592-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance … |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0591-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonanc… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0590-2022 |
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance… |
— |
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-11-04 |
Class II
|
Ongoing |
Z-0524-2022 |
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi" |
— |
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal … |
| 2021-11-04 |
Class II
|
Ongoing |
Z-0523-2022 |
GE Vscan Extend, being sold as "Vscan Extend Sector USB" |
— |
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal … |
| 2021-11-04 |
Class II
|
Ongoing |
Z-0522-2022 |
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM" |
— |
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal … |
| 2021-11-04 |
Class II
|
Ongoing |
Z-0521-2022 |
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi" |
— |
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal … |
| 2021-11-04 |
Class II
|
Ongoing |
Z-0520-2022 |
GE Vscan Extend, being sold as "Vscan Extend Dual USB" |
— |
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal … |
| 2021-11-04 |
Class II
|
Ongoing |
Z-0519-2022 |
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM" |
— |
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal … |
| 2021-11-04 |
Class II
|
Ongoing |
Z-0518-2022 |
GE Vscan Extend, being sold as "Vscan Extend Console" |
— |
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal … |
| 2021-10-15 |
Class II
|
Ongoing |
Z-0329-2022 |
GE Centricity Universal Viewer Zero Footprint Client |
— |
There is a potential to display incomplete patient imaging study. |
| 2021-08-26 |
Class II
|
Terminated |
Z-0141-2022 |
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system |
— |
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| 2021-08-26 |
Class II
|
Terminated |
Z-0140-2022 |
Optima MR450w 1.5T nuclear magnetic resonance imaging system |
— |
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| 2021-08-26 |
Class II
|
Terminated |
Z-0139-2022 |
SIGNA Artist nuclear magnetic resonance imaging system |
— |
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| 2021-08-26 |
Class II
|
Terminated |
Z-0138-2022 |
SIGNA Voyager nuclear magnetic resonance imaging system |
— |
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| 2021-08-26 |
Class II
|
Terminated |
Z-0137-2022 |
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system |
— |
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| 2021-08-26 |
Class II
|
Terminated |
Z-0136-2022 |
Discovery MR750 3.0T nuclear magnetic resonance imaging system |
— |
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| 2021-08-26 |
Class II
|
Terminated |
Z-0135-2022 |
Discovery MR750w 3.0T nuclear magnetic resonance imaging system |
— |
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| 2021-08-26 |
Class II
|
Terminated |
Z-0134-2022 |
SIGNA Pioneer nuclear magnetic resonance imaging system |
— |
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| 2021-08-26 |
Class II
|
Terminated |
Z-0133-2022 |
SIGNA Architect nuclear magnetic resonance imaging system |
— |
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| 2021-08-26 |
Class II
|
Terminated |
Z-0132-2022 |
SIGNA Premier nuclear magnetic resonance imaging system |
— |
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| 2021-08-12 |
Class II
|
Terminated |
Z-0012-2022 |
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system |
— |
A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterpr… |
| 2021-08-06 |
Class II
|
Ongoing |
Z-2503-2021 |
Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammogra… |
— |
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive |
| 2021-08-06 |
Class II
|
Ongoing |
Z-2502-2021 |
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms… |
— |
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2596-2021 |
Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (… |
— |
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine… |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2595-2021 |
Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSO… |
— |
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine… |
| 2021-06-30 |
Class II
|
Ongoing |
Z-2023-2021 |
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission da… |
— |
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the int… |
| 2021-06-30 |
Class II
|
Ongoing |
Z-2022-2021 |
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission pr… |
— |
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the int… |
| 2021-06-30 |
Class II
|
Ongoing |
Z-2021-2021 |
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission pr… |
— |
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the int… |
| 2021-06-30 |
Class II
|
Ongoing |
Z-0816-2022 |
Revolution CT, Revolution CT ES |
— |
The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccuratel… |
| 2021-06-30 |
Class II
|
Ongoing |
Z-0815-2022 |
Revolution Apex, Revolution CT with Apex Edition |
— |
The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccuratel… |
| 2021-06-30 |
Class II
|
Ongoing |
Z-0242-2022 |
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition |
— |
The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is … |
| 2021-06-24 |
Class II
|
Terminated |
Z-2590-2021 |
AMX Navigate Mobile X-Ray System |
— |
An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system. |
| 2021-06-14 |
Class II
|
Ongoing |
Z-1900-2021 |
Revolution EVO, Optima CT660, Optima CT680 CT Systems. |
— |
Improperly loaded software options may result in additional X -ray radiation exposure to the patient. |
| 2021-06-04 |
Class II
|
Ongoing |
Z-2065-2021 |
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System |
— |
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked wh… |
| 2021-06-04 |
Class II
|
Ongoing |
Z-2064-2021 |
Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System |
— |
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked wh… |
| 2021-06-04 |
Class II
|
Ongoing |
Z-2063-2021 |
Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System |
— |
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked wh… |
| 2021-06-04 |
Class II
|
Ongoing |
Z-2062-2021 |
SIGNA Voyager, Nuclear Magnetic Resonance Imaging System |
— |
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked wh… |
| 2021-06-04 |
Class II
|
Ongoing |
Z-2061-2021 |
SIGNA Artist, Nuclear Magnetic Resonance Imaging System |
— |
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked wh… |
| 2021-06-04 |
Class II
|
Ongoing |
Z-2060-2021 |
SIGNA MR380, Nuclear Magnetic Resonance Imaging System |
— |
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked wh… |
| 2021-06-04 |
Class II
|
Ongoing |
Z-2059-2021 |
SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System |
— |
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked wh… |
| 2021-06-04 |
Class II
|
Ongoing |
Z-2058-2021 |
SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System |
— |
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked wh… |
| 2021-06-04 |
Class II
|
Ongoing |
Z-2057-2021 |
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
— |
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked wh… |
| 2021-06-04 |
Class II
|
Ongoing |
Z-2056-2021 |
Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, hi… |
— |
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked wh… |
| 2021-06-04 |
Class II
|
Ongoing |
Z-2055-2021 |
Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, h… |
— |
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked wh… |
| 2021-06-04 |
Class II
|
Ongoing |
Z-2054-2021 |
SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high sign… |
— |
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked wh… |
| 2021-06-04 |
Class II
|
Ongoing |
Z-2053-2021 |
SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high si… |
— |
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked wh… |
| 2021-06-04 |
Class II
|
Ongoing |
Z-2052-2021 |
SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high sign… |
— |
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked wh… |
| 2021-05-21 |
Class II
|
Ongoing |
Z-2139-2021 |
CARESCAPE PDM-Masimo SpO2. Physiological data monitor. |
— |
Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down. |
| 2021-04-19 |
Class II
|
Terminated |
Z-1927-2021 |
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG applica… |
— |
If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an Electronic … |
| 2021-04-19 |
Class II
|
Terminated |
Z-1864-2021 |
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614)… |
— |
The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image p… |
| 2021-03-19 |
Class II
|
Completed |
Z-2004-2021 |
Revolution CT |
— |
GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue… |
| 2021-03-19 |
Class II
|
Terminated |
Z-1533-2021 |
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, an… |
— |
When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the v… |
| 2021-02-07 |
Class II
|
Ongoing |
Z-1547-2021 |
NM/CT 870 DR Nuclear Medicine / CT Scanners |
— |
GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared … |
| 2021-02-07 |
Class II
|
Ongoing |
Z-1546-2021 |
NM/CT 860 Nuclear Medicine / CT Scanners |
— |
GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared … |
| 2021-02-07 |
Class II
|
Ongoing |
Z-1545-2021 |
NM/CT 850 Nuclear Medicine / CT Scanners |
— |
GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared t… |
| 2020-12-17 |
Class II
|
Terminated |
Z-1130-2021 |
System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES. |
— |
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the t… |
| 2020-12-17 |
Class II
|
Terminated |
Z-1129-2021 |
System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition |
— |
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the t… |
| 2020-12-10 |
Class II
|
Terminated |
Z-1101-2021 |
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use … |
— |
GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A partial detach… |
| 2020-12-10 |
Class II
|
Ongoing |
Z-0858-2021 |
Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for dete… |
— |
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings… |
| 2020-12-10 |
Class II
|
Ongoing |
Z-0857-2021 |
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery … |
— |
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings… |
| 2020-12-10 |
Class II
|
Ongoing |
Z-0856-2021 |
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Pr… |
— |
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings… |
| 2020-12-10 |
Class II
|
Ongoing |
Z-0855-2021 |
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures f… |
— |
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings… |
| 2020-12-10 |
Class II
|
Ongoing |
Z-0854-2021 |
GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for d… |
— |
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings… |
| 2020-12-10 |
Class II
|
Ongoing |
Z-0853-2021 |
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for d… |
— |
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings… |
| 2020-11-23 |
Class II
|
Terminated |
Z-0695-2021 |
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Com… |
— |
A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling |
| 2020-11-23 |
Class II
|
Terminated |
Z-0694-2021 |
Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applicat… |
— |
A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling |
| 2020-10-27 |
Class II
|
Terminated |
Z-0543-2021 |
MAC VU360, Electrocardiograph |
— |
Incorrect patient identification and/or patient demographic errors. |
| 2020-09-21 |
Class II
|
Terminated |
Z-0306-2021 |
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whol… |
— |
There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings. |
| 2020-09-17 |
Class II
|
Ongoing |
Z-0317-2021 |
Flow Sensor Service Part, Catalog 2096513-001-S |
— |
Flow sensors could have damaged tubes in the form of small punctures or cuts. |
| 2020-09-17 |
Class II
|
Ongoing |
Z-0316-2021 |
Flow Sensor Service Part, Catalog 2087640-001-S |
— |
Flow sensors could have damaged tubes in the form of small punctures or cuts. |
| 2020-09-17 |
Class II
|
Ongoing |
Z-0315-2021 |
Flow Sensor Service Part, Catalog 2089610-001-S |
— |
Flow sensors could have damaged tubes in the form of small punctures or cuts. |
| 2020-09-17 |
Class II
|
Ongoing |
Z-0314-2021 |
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only. |
— |
Flow sensors could have damaged tubes in the form of small punctures or cuts. |
| 2020-09-17 |
Class II
|
Ongoing |
Z-0313-2021 |
GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ve… |
— |
Flow sensors could have damaged tubes in the form of small punctures or cuts. |
| 2020-09-17 |
Class II
|
Ongoing |
Z-0312-2021 |
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and vent… |
— |
Flow sensors could have damaged tubes in the form of small punctures or cuts. |
| 2020-09-17 |
Class II
|
Ongoing |
Z-0311-2021 |
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set… |
— |
Flow sensors could have damaged tubes in the form of small punctures or cuts. |
| 2020-09-08 |
Class II
|
Terminated |
Z-0131-2021 |
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined … |
— |
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. |
| 2020-09-08 |
Class II
|
Terminated |
Z-0130-2021 |
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to suppo… |
— |
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. |
| 2020-09-08 |
Class II
|
Terminated |
Z-0129-2021 |
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to suppo… |
— |
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. |
| 2020-09-08 |
Class II
|
Terminated |
Z-0128-2021 |
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to suppo… |
— |
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. |
| 2020-09-08 |
Class II
|
Terminated |
Z-0127-2021 |
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to suppo… |
— |
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. |
| 2020-08-14 |
Class II
|
Terminated |
Z-2998-2020 |
NM/CT 870 DR Model # H3100AS |
— |
Rotor bearing screws were found loose on detector. |
| 2020-08-14 |
Class II
|
Terminated |
Z-2997-2020 |
Discovery NM670 Pro Model # H3100XB |
— |
Rotor bearing screws were found loose on detector. |
| 2020-08-14 |
Class II
|
Terminated |
Z-2996-2020 |
Discovery 670 DR Model # H3100BT |
— |
Rotor bearing screws were found loose on detector. |
| 2020-08-14 |
Class II
|
Terminated |
Z-2995-2020 |
NM 830 Model # H3910AC |
— |
Rotor bearing screws were found loose on detector. |
| 2020-08-14 |
Class II
|
Terminated |
Z-2994-2020 |
Discovery NM 630 Model # H3101RH |
— |
Rotor bearing screws were found loose on detector. |
| 2020-08-14 |
Class II
|
Terminated |
Z-2993-2020 |
NM/CT 870 CZT Model # H3906CW |
— |
Rotor bearing screws were found loose on detector. |
| 2020-08-14 |
Class II
|
Terminated |
Z-2992-2020 |
NM/CT 860, SPECT/CT |
— |
Rotor bearing screws were found loose on detector. |
| 2020-08-14 |
Class II
|
Terminated |
Z-2991-2020 |
NM/CT 850 Model Number: H3907AD |
— |
Rotor bearing screws were found loose on detector. |
| 2020-07-14 |
Class II
|
Terminated |
Z-2883-2020 |
CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumat… |
— |
The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered. |
| 2020-06-22 |
Class II
|
Terminated |
Z-2750-2020 |
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor an… |
— |
CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE… |
| 2020-05-18 |
Class II
|
Ongoing |
Z-2424-2020 |
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transp… |
— |
The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is tur… |
| 2020-05-08 |
Class II
|
Ongoing |
Z-2872-2020 |
The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical a… |
— |
GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had reque… |
| 2020-04-28 |
Class II
|
Terminated |
Z-2236-2020 |
Giraffe Incubator with installed Servo Oxygen module. Infant incubator. |
— |
Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certa… |
| 2020-04-28 |
Class II
|
Terminated |
Z-2235-2020 |
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer. |
— |
Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certa… |
| 2020-04-02 |
Class II
|
Terminated |
Z-2111-2020 |
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808. |
— |
During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor. |