| 2026-07-16 |
Class II
|
Ongoing |
Z-2932-2026 |
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Versi… |
— |
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment… |
| 2026-07-16 |
Class II
|
Ongoing |
Z-2931-2026 |
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, … |
— |
Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complicat… |
| 2026-05-18 |
Class II
|
Ongoing |
Z-2412-2026 |
Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xp… |
— |
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended … |
| 2026-05-18 |
Class II
|
Ongoing |
Z-2411-2026 |
Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034… |
— |
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended … |
| 2026-04-30 |
Class II
|
Ongoing |
Z-2259-2026 |
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR T… |
— |
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of servi… |
| 2026-04-30 |
Class II
|
Ongoing |
Z-2258-2026 |
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222),… |
— |
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of servi… |
| 2026-04-28 |
Class II
|
Ongoing |
Z-2229-2026 |
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integ… |
— |
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oi… |
| 2026-04-28 |
Class II
|
Ongoing |
Z-2228-2026 |
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura X… |
— |
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oi… |
| 2026-04-28 |
Class II
|
Ongoing |
Z-2227-2026 |
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (… |
— |
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oi… |
| 2026-04-28 |
Class II
|
Ongoing |
Z-2225-2026 |
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions an… |
— |
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Table… |
| 2026-03-31 |
Class II
|
Ongoing |
Z-2170-2026 |
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230),… |
— |
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over tim… |
| 2026-03-19 |
Class II
|
Ongoing |
Z-1805-2026 |
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended… |
— |
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio… |
| 2026-03-05 |
Class II
|
Ongoing |
Z-1692-2026 |
Vue Motion V12. Product Number: 1017979. |
— |
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1680-2026 |
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1679-2026 |
Azurion 5 M12; System Code: (1)722227, (2)722231; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1678-2026 |
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1677-2026 |
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1676-2026 |
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1675-2026 |
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1674-2026 |
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1673-2026 |
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1672-2026 |
Allura Xper FD20/15 OR Table; System Code: 722059; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1671-2026 |
Allura Xper FD20/15; System Code: 722058; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1670-2026 |
Allura Xper FD20/20 OR Table; System Code: 722039; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1669-2026 |
Allura Xper FD20/20; System Code: 722038; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1668-2026 |
Allura Xper FD20/10; System Code: 722029; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1667-2026 |
ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1666-2026 |
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1665-2026 |
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1664-2026 |
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1663-2026 |
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1662-2026 |
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1661-2026 |
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1660-2026 |
ALLURA Xper FD10F; System Code: 722002; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1659-2026 |
Allura Xper FD10C; System Code: 722001; |
— |
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| 2026-01-26 |
Class II
|
Ongoing |
Z-1351-2026 |
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions:… |
— |
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| 2026-01-26 |
Class II
|
Ongoing |
Z-1350-2026 |
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X |
— |
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| 2026-01-26 |
Class II
|
Ongoing |
Z-1349-2026 |
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - Al… |
— |
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| 2026-01-26 |
Class II
|
Ongoing |
Z-1348-2026 |
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.… |
— |
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| 2026-01-26 |
Class II
|
Ongoing |
Z-1347-2026 |
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.… |
— |
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| 2026-01-26 |
Class II
|
Ongoing |
Z-1346-2026 |
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R… |
— |
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| 2026-01-26 |
Class II
|
Ongoing |
Z-1345-2026 |
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number -… |
— |
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| 2026-01-26 |
Class II
|
Ongoing |
Z-1344-2026 |
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, … |
— |
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1077-2026 |
Allura Xper FD20/20; Model Number: 722038; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1076-2026 |
Allura Xper FD20/10; Model Number: 722029; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1075-2026 |
Allura Xper FD20; Model Number: 722028; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1074-2026 |
Allura Xper FD10/10; Model Number: 722027; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1073-2026 |
Allura Xper FD10; Model Number: 722026; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1072-2026 |
Allura Xper FD20 OR Table; Model Number: 722023; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1071-2026 |
Allura Xper FD20 Biplane; Model Number: 722013; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1070-2026 |
Allura Xper FD20; Model Number: 722012; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1069-2026 |
Allura Xper FD10/10; Model Number: 722011; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1068-2026 |
Allura Xper FD10; Model Number: 722010; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1067-2026 |
Allura Xper FD20 Biplane; Model Number: 722008; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1066-2026 |
Allura Xper FD20; Model Number: 722006; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1065-2026 |
Allura Xper FD10/10; Model Number: 722005; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1064-2026 |
Allura Xper FD10; Model Number: 722003; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1063-2026 |
Allura Xper FD10F; Model Number: 722002; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1062-2026 |
Product Name: Allura Xper FD10C; Model number: 722001; |
— |
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, o… |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1113-2026 |
Philips Azurion system; Software Version Number: R3.1; |
— |
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movem… |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1091-2026 |
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corres… |
— |
Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free spa… |
| 2025-12-08 |
Class II
|
Ongoing |
Z-1079-2026 |
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. M… |
— |
Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the… |
| 2025-10-02 |
Class II
|
Ongoing |
Z-0719-2026 |
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234; |
— |
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease lea… |
| 2025-09-29 |
Class II
|
Ongoing |
Z-0241-2026 |
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system |
— |
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (II… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-2635-2025 |
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162… |
— |
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If th… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-2634-2025 |
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419… |
— |
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If th… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-2633-2025 |
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615… |
— |
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If th… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-2632-2025 |
Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615… |
— |
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If th… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-2631-2025 |
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419… |
— |
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If th… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-2630-2025 |
Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615… |
— |
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If th… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-2629-2025 |
Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K13… |
— |
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If th… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-2628-2025 |
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842,… |
— |
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If th… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-2627-2025 |
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K13… |
— |
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If th… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-2626-2025 |
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638,… |
— |
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If th… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-2625-2025 |
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K1… |
— |
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If th… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-2624-2025 |
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K1306… |
— |
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If th… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-2623-2025 |
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638,… |
— |
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If th… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0015-2026 |
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979… |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0014-2026 |
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16… |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0013-2026 |
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, … |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0012-2026 |
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, … |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0011-2026 |
Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, … |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0010-2026 |
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, … |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0009-2026 |
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, … |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0008-2026 |
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K1… |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0007-2026 |
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K13084… |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0006-2026 |
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K13329… |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0005-2026 |
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K1… |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0004-2026 |
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K16… |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0003-2026 |
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842,… |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0002-2026 |
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K1… |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0001-2026 |
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16… |
— |
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be… |
| 2025-08-08 |
Class II
|
Ongoing |
Z-2543-2025 |
IntelliSpace Cardiovascular, Software 8.0.0.4. |
— |
Software issue that results in the display of outdated information. |
| 2025-08-01 |
Class II
|
Ongoing |
Z-2504-2025 |
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model… |
— |
Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series. |
| 2025-08-01 |
Class II
|
Ongoing |
Z-2503-2025 |
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corre… |
— |
Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if … |
| 2025-08-01 |
Class II
|
Ongoing |
Z-2502-2025 |
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresp… |
— |
Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if … |
| 2025-06-30 |
Class II
|
Ongoing |
Z-2189-2025 |
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper… |
— |
Potential for temporary loss of imaging (X-ray) functionality due to software issue. |
| 2025-06-04 |
Class II
|
Ongoing |
Z-2134-2025 |
Azurion 7 M20. Fluoroscopic X-Ray System. |
— |
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. |
| 2025-05-28 |
Class II
|
Ongoing |
Z-1969-2025 |
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (… |
— |
A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) fun… |
| 2025-04-07 |
Class II
|
Ongoing |
Z-1740-2025 |
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089. |
— |
An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report. |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1783-2025 |
SmartPath to dStream for 3.0T, Model Number: 782145; |
— |
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… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1782-2025 |
SmartPath to dStream for 1.5T, Model Number: 782146; |
— |
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… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1781-2025 |
Intera CV, Model Number: 781107; |
— |
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… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1780-2025 |
Intera 3.0T Quasar Dual, Model Number: 781150; |
— |
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… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1779-2025 |
Intera 1.5T R11, Model Number: 781170; |
— |
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… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1778-2025 |
Intera 1.5T Power/Pulsar, Model Number: 781105; |
— |
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… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1777-2025 |
Intera 1.5T Omni/Stellar, Model Number: 781104; |
— |
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… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1776-2025 |
Intera 1.5T Master/Nova, Model Number: 781106; |
— |
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… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1775-2025 |
Intera 1.5T Explorer/Nova Dual, Model Number: 781108; |
— |
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… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1774-2025 |
Intera 1.5T, Model Numbers: 781195 and 781295; |
— |
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… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1773-2025 |
Intera 1.0T Power/Pulsar, Model Number: 781103; |
— |
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… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1772-2025 |
Intera 1.0T Omni/Stellar, Model Number: 781102; |
— |
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… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1771-2025 |
Intera 0.5T Standard, Model Number: 781101; |
— |
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… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1770-2025 |
Enterprise 1.5T, Model Number: 781145; |
— |
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… |
| 2025-02-28 |
Class II
|
Ongoing |
Z-1324-2025 |
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334; |
— |
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1161-2025 |
Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1160-2025 |
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY); |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1159-2025 |
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY). |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1158-2025 |
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236. |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1157-2025 |
Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY). |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1156-2025 |
Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY). |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1155-2025 |
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY). |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1154-2025 |
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY). |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1153-2025 |
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221. |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1152-2025 |
Allura Xper FD10C; Catalog number: 722001 |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1151-2025 |
Allura CV20; Catalog numbers: 722031 |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1150-2025 |
Allura Xper FD20/20; Catalog numbers: 722038 |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1149-2025 |
Allura Xper FD20/15; Catalog numbers: 722058 |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1148-2025 |
Allura Xper FD20/10; Catalog numbers: 722029 |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1147-2025 |
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035. |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1146-2025 |
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025. |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1145-2025 |
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013. |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1144-2025 |
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028. |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1143-2025 |
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027. |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class I
|
Ongoing |
Z-1142-2025 |
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026, |
— |
Possibility of the patient falling from the table related to the mattress used on the patient table. |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1094-2025 |
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 … |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1093-2025 |
Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1092-2025 |
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1091-2025 |
Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1090-2025 |
Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1089-2025 |
Azurion 5 M12 System Code: (1) 722227 (2) 722231 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1088-2025 |
Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1087-2025 |
Azurion 3 M12 System Code: (1) 722063 (2) 722221 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1086-2025 |
AlluraXperFD20/15 System Code: (1) 722058 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1085-2025 |
Allura Xper FD20/20 System Code: (1) 722038 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1084-2025 |
AlluraXperFD20/10 System Code: (1) 722029 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1083-2025 |
AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1082-2025 |
AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1081-2025 |
AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1080-2025 |
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1079-2025 |
Allura Xper FD10C System Code: (1) 722001 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1078-2025 |
AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1077-2025 |
Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2025-01-13 |
Class II
|
Ongoing |
Z-1076-2025 |
Allura CV20 System Code: 722031 |
— |
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repo… |
| 2024-11-11 |
Class II
|
Ongoing |
Z-0676-2025 |
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. … |
— |
Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under invest… |
| 2024-10-07 |
Class II
|
Ongoing |
Z-0353-2025 |
Philips Zenition 70, Model Number: 718133 |
— |
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure. |
| 2024-10-07 |
Class II
|
Ongoing |
Z-0352-2025 |
Philips Zenition 50, Model Number: 718096 |
— |
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure. |
| 2024-08-22 |
Class II
|
Ongoing |
Z-3168-2024 |
System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDia… |
— |
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, an… |
| 2024-08-22 |
Class II
|
Ongoing |
Z-3167-2024 |
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allur… |
— |
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, an… |
| 2024-08-22 |
Class II
|
Ongoing |
Z-3166-2024 |
System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 A… |
— |
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, an… |
| 2024-08-22 |
Class II
|
Ongoing |
Z-3165-2024 |
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M… |
— |
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, an… |
| 2024-08-08 |
Class II
|
Ongoing |
Z-2716-2024 |
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722… |
— |
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt. |
| 2024-08-06 |
Class II
|
Ongoing |
Z-2953-2024 |
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Number… |
— |
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease lea… |
| 2024-07-15 |
Class II
|
Ongoing |
Z-2534-2024 |
Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for I… |
— |
Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart |
| 2024-05-16 |
Class II
|
Ongoing |
Z-1897-2024 |
Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1… |
— |
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected mo… |
| 2024-05-16 |
Class II
|
Ongoing |
Z-1896-2024 |
Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100. |
— |
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected mo… |
| 2024-05-16 |
Class II
|
Ongoing |
Z-1895-2024 |
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100. |
— |
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected mo… |
| 2024-05-02 |
Class II
|
Ongoing |
Z-1926-2024 |
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of … |
— |
Potential for pressure wave data synchronization from two devices may not be correct. |
| 2024-04-04 |
Class II
|
Ongoing |
Z-1252-2025 |
Philips IntelliSpace Cardiovascular software, Model 830089. |
— |
Study data is not able to be archived, copied, or exported with the cardiovascular software version. |
| 2024-02-06 |
Class II
|
Ongoing |
Z-1178-2024 |
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg… |
— |
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it wi… |
| 2024-02-06 |
Class II
|
Ongoing |
Z-1177-2024 |
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg… |
— |
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it wi… |
| 2024-02-06 |
Class II
|
Ongoing |
Z-1176-2024 |
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive sur… |
— |
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it wi… |
| 2024-01-02 |
Class II
|
Ongoing |
Z-1156-2024 |
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used… |
— |
Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. |
| 2024-01-02 |
Class II
|
Ongoing |
Z-1152-2024 |
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected… |
— |
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. |
| 2024-01-02 |
Class II
|
Ongoing |
Z-1151-2024 |
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected… |
— |
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. |
| 2024-01-02 |
Class II
|
Ongoing |
Z-1145-2024 |
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected… |
— |
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen im… |
| 2024-01-02 |
Class II
|
Ongoing |
Z-1144-2024 |
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected… |
— |
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen im… |
| 2023-12-12 |
Class II
|
Ongoing |
Z-0835-2024 |
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -7… |
— |
System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a pro… |
| 2023-12-08 |
Class II
|
Ongoing |
Z-0861-2024 |
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) |
— |
Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movemen… |
| 2023-12-08 |
Class II
|
Ongoing |
Z-0860-2024 |
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) |
— |
Loss of connectivity between the FlexArm and the Table due to a software issue. |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0559-2024 |
Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion… |
— |
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.… |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0558-2024 |
Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 … |
— |
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.… |
| 2023-08-15 |
Class II
|
Ongoing |
Z-2587-2023 |
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems |
— |
A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible. |
| 2023-07-20 |
Class II
|
Ongoing |
Z-1583-2025 |
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as w… |
— |
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch. |
| 2023-07-19 |
Class II
|
Ongoing |
Z-2404-2023 |
MultiDiagnost-Eleva |
— |
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation |
| 2023-07-19 |
Class II
|
Ongoing |
Z-2403-2023 |
Azurion |
— |
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation |
| 2023-07-19 |
Class II
|
Ongoing |
Z-2402-2023 |
Allura Xper series |
— |
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation |
| 2023-06-30 |
Class II
|
Ongoing |
Z-2485-2023 |
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems |
— |
Loss of availability of the wireless foot switch during procedures. |
| 2023-06-12 |
Class II
|
Ongoing |
Z-2284-2023 |
Azurion 7 M20. X-ray Image guided Therapy System. |
— |
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage. |
| 2023-06-12 |
Class II
|
Ongoing |
Z-2283-2023 |
Allura Xper FD10 and FD20. X-ray Imaging System. |
— |
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage. |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1647-2023 |
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) A… |
— |
Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the proce… |
| 2023-02-20 |
Class II
|
Ongoing |
Z-1417-2023 |
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 |
— |
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations. |
| 2023-02-20 |
Class II
|
Ongoing |
Z-1416-2023 |
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 |
— |
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations. |
| 2021-12-02 |
Class II
|
Ongoing |
Z-0649-2022 |
Veradius Unity, Model #718132 |
— |
Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or… |
| 2021-12-02 |
Class II
|
Ongoing |
Z-0648-2022 |
Zenition 70, Model #718133 |
— |
Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or… |
| 2021-12-02 |
Class II
|
Ongoing |
Z-0647-2022 |
Zenition 50, Model #718096 |
— |
Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or… |
| 2021-05-26 |
Class II
|
Ongoing |
Z-0886-2022 |
Azurion systems with software release R1.x |
— |
In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Pa… |