Browse Device Recalls

685 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 685 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 685 FDA device recalls.

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DateProductReasonClassFirm
Jan 2, 2024 Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically t... Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 2, 2024 Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the D... Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 2, 2024 Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically t... Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 2, 2024 Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the D... Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 13, 2023 Spectral CT on Rails: Software Version 5.1.0.X, model 728334. A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... Class II PHILIPS MEDICAL SYSTEMS
Dec 13, 2023 Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 Chi... A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... Class II PHILIPS MEDICAL SYSTEMS
Dec 12, 2023 Philips Azurion system, Interventional fluoroscopic x-ray system. System P... System may exhibit a loss of imaging functionality and data due to an issue which can cause the s... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 8, 2023 Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table... Loss of connectivity between the FlexArm and the Table due to a software issue related to the dat... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 8, 2023 Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table... Loss of connectivity between the FlexArm and the Table due to a software issue. Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Nov 3, 2023 Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura X... Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Nov 3, 2023 Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion ... Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Aug 15, 2023 Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and Mu... A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiatio... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jul 20, 2023 Zenition 70. The device is to be used in health care facilities both inside a... Philips has become aware of the potential for unintended radiation exposure with Zenition 70 syst... Class II Philips Medical Systems Nederland B.V.
Jul 19, 2023 MultiDiagnost-Eleva A foot switch pedal may get stuck in the active position when the user releases the pedal, resul... Class II Philips Medical Systems Nederland B.V.
Jul 19, 2023 Azurion A foot switch pedal may get stuck in the active position when the user releases the pedal, resul... Class II Philips Medical Systems Nederland B.V.
Jul 19, 2023 Allura Xper series A foot switch pedal may get stuck in the active position when the user releases the pedal, resul... Class II Philips Medical Systems Nederland B.V.
Jun 30, 2023 Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interve... Loss of availability of the wireless foot switch during procedures. Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 12, 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 i... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 12, 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 i... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 21, 2023 Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.... Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Feb 20, 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 inaccur... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Feb 20, 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 inaccur... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Aug 30, 2022 Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. When computing a radiation dose in the system, the exported dose information is incorrect when th... Class II Philips Medical Systems (Cleveland) Inc
Feb 11, 2022 CombiDiagnost R90 1.0 (709030) While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) ... Class II PHILIPS MEDICAL SYSTEMS
Feb 11, 2022 CombiDiagnost R90 1.1 (709031) While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) ... Class II PHILIPS MEDICAL SYSTEMS
Dec 2, 2021 Zenition 70, Model #718133 Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issu... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 2, 2021 Veradius Unity, Model #718132 Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issu... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 2, 2021 Zenition 50, Model #718096 Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issu... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
May 26, 2021 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 St... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
May 19, 2021 DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system Following a system restart where the Table Height 2 (TH2) is the default setting and then switche... Class II Philips Medical Systems DMC GmbH
May 19, 2021 DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system Following a system restart where the Table Height 2 (TH2) is the default setting and then switche... Class II Philips Medical Systems DMC GmbH
May 19, 2021 DigitalDiagnost C90 High Performance. radiography and fluoroscopy system Following a system restart where the Table Height 2 (TH2) is the default setting and then switche... Class II Philips Medical Systems DMC GmbH
May 19, 2021 ProxiDiagnost N90. radiography and fluoroscopy system Following a system restart where the Table Height 2 (TH2) is the default setting and then switche... Class II Philips Medical Systems DMC GmbH
May 19, 2021 DigitalDiagnost 4 High Performance. radiography and fluoroscopy system Following a system restart where the Table Height 2 (TH2) is the default setting and then switche... Class II Philips Medical Systems DMC GmbH
Jul 22, 2020 CombiDiagnost R90 Software Version R1.0 and R1.1 Philips has become aware of a software issue, where the kV and mA values are not locked immediate... Class II Philips Medical Systems Gmbh, DMC
Dec 19, 2019 CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xr... When using the Table Up/Down button, the system may experience Error 80, which locks the geometry... Class II Philips Medical Systems Gmbh, DMC
Dec 19, 2019 CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xr... When using the Table Up/Down button, the system may experience Error 80, which locks the geometry... Class II Philips Medical Systems Gmbh, DMC
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... Class I Philips Medical Systems (Cleveland) Inc
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... Class I Philips Medical Systems (Cleveland) Inc
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... Class I Philips Medical Systems (Cleveland) Inc
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... Class I Philips Medical Systems (Cleveland) Inc
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... Class I Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 IQon Spectral CT Model # 728332, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Vereos PET/CT Model # 882446, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Ingenuity Core Model # 728321, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 iCT SP Model # 728311, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Ingenuity CT, Model # 728326, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 iCT, Model # 728306, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Brilliance 64 Model # 728231, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc

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.