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Browse Device Recalls

209 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 209 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 209 FDA device recalls.

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DateProductReasonClassFirm
Jul 16, 2026 Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 7220... Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degr... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jul 16, 2026 Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 7222... Two software related issues: 1) Potential image quality degradation that may lead to delay of t... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 29, 2026 Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038... Firmware issue potentially leading to loss of geometry movements. Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 17, 2026 Philips Allura under the following System Descriptions and corresponding mode... Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unaut... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 17, 2026 Philips Azurion under the following System Descriptions and corresponding mod... Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unaut... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 17, 2026 Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Inte... Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unaut... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
May 18, 2026 Philips Allura Xper with the following Model Numbers: Model # 722001 for Allu... Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing poten... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
May 18, 2026 Philips MultiDiagnost Eleva with the following Model Numbers: Model # 7080... Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing poten... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Apr 30, 2026 Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722... It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Apr 30, 2026 Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (72206... It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Apr 28, 2026 Allura system; System Code Description (Model Numbers): Allura Xper FD10C (72... The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 a... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Apr 28, 2026 Integris-Allura system; System Code Description (Model Numbers): Integris CV ... The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 a... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Apr 28, 2026 Philips Azurion systems not configured with an optional auxiliary pan handle.... Potential safety issue with Philips Azurion systems, where longitudinal and transverse table move... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Apr 28, 2026 Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (72206... The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 a... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 31, 2026 Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (72222... Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 19, 2026 Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software me... Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (I... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 5, 2026 Vue Motion V12. Product Number: 1017979. Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 2026 Allura Xper FD10C; System Code: 722001; Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 2026 Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS o... Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 2026 Allura Xper FD20/20; System Code: 722038; Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 2026 Allura Xper FD20/15; System Code: 722058; Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 2026 Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS O... Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 2026 Allura Xper FD20/10; System Code: 722029; Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 2026 ALLURA Xper FD10F; System Code: 722002; Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 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 intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Softwa... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Sof... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)7... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version ... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Soft... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)7222... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Softwa... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD20; Model Number: 722006; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD10; Model Number: 722026; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD20 Biplane; Model Number: 722013; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.