Browse Device Recalls

421 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 421 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 421 FDA device recalls.

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DateProductReasonClassFirm
Dec 29, 2023 Achieva 1.5T, Model No. 781178, 781196, 781296 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 29, 2023 Intera 1.5T, Model No. 781195 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 29, 2023 SmartPath to dStream for 1.5T, Model No. 781260, 782112 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 29, 2023 Achieva 3.0T, Model No. 781177 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 15, 2023 BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478... Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce... Class I Philips North America
Dec 15, 2023 BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 8824... Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce... Class I Philips North America
Dec 15, 2023 ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/... Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s ra... Class II Philips North America
Dec 15, 2023 ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy... Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients rad... Class II Philips North America
Dec 15, 2023 BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12... Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce... Class I Philips North America
Dec 7, 2023 Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray Syste... If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily ope... Class II Philips North America
Nov 30, 2023 Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. Multiple software issues that affect device functionality. Class II Philips North America Llc
Nov 30, 2023 BrightView XCT, Gamma Camera, Product Code 882482 While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created be... Class II Philips North America
Nov 30, 2023 BrightView, Gamma Camera System, Product Code 882480. While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created be... Class II Philips North America
Nov 30, 2023 BrightView X, Gamma Camera, Product Code 882478 While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created be... Class II Philips North America
Nov 28, 2023 (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436 Push notifications may fail to send to the user under certain conditions. This could potentially ... Class II Philips North America
Nov 28, 2023 (1) Patient Information Center iX, Model No. 866389 (2) Patient Information ... Push notifications may fail to send to the user under certain conditions. This could potentially ... Class II Philips North America
Nov 17, 2023 Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 7... Firm was informed of an event in which the structural integrity of the MR system components faile... Class I Philips North America Llc
Oct 23, 2023 Intera 1.5T Potential component failure in the Gradient Coil could product smoke and/or fire. Class II Philips North America Llc
Oct 23, 2023 Intera 1.5T Power/Pulsar Potential component failure in the Gradient Coil could product smoke and/or fire. Class II Philips North America Llc
Oct 23, 2023 Achieva 1.5T Conversion Potential component failure in the Gradient Coil could product smoke and/or fire. Class II Philips North America Llc
Oct 23, 2023 Achieva 1.5T Initial System Potential component failure in the Gradient Coil could product smoke and/or fire. Class II Philips North America Llc
Oct 23, 2023 Achieva 1.5T Potential component failure in the Gradient Coil could product smoke and/or fire. Class II Philips North America Llc
Oct 23, 2023 Ingenia 1.5T CX Potential component failure in the Gradient Coil could product smoke and/or fire. Class II Philips North America Llc
Oct 23, 2023 SmartPath to dStream for 1.5T Potential component failure in the Gradient Coil could product smoke and/or fire. Class II Philips North America Llc
Oct 9, 2023 Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728... For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... Class II Philips North America Llc
Oct 9, 2023 Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the ope... Class II Philips North America
Oct 9, 2023 Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner ... For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... Class II Philips North America Llc
Oct 9, 2023 Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT... For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... Class II Philips North America Llc
Oct 9, 2023 Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 This recall is part of a 2-issue recall for the same system. When using the IVC needle position b... Class II Philips North America
Oct 4, 2023 Integris-Allura IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 Azurion IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 Zenition 50 & 70 Mobile Surgery C-arm Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 Veradius Unity Mobile Surgery C-arm Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surge... Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 Allura Xper IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Sep 21, 2023 DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and ex... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display a... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, dis... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost C90 High Performance, used to acquire, process, store, displa... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost C90 Release 3, used to acquire, process, store, display and e... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost 4 High Performance, used to acquire, process, store, display ... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display a... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Aug 31, 2023 EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidest... A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... Class II Philips North America Llc
Aug 31, 2023 EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream e... A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... Class II Philips North America Llc
Aug 17, 2023 Patient Information Center iX with Software Version Number 4.x in the followi... Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driv... Class II Philips North America Llc
Jun 14, 2023 IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01... Devices with Option CP2 and initially programmed to software version P.01.01 were configured inco... Class II Philips North America Llc
Jun 12, 2023 Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and ... During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector... Class II Philips North America

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.