Browse Device Recalls

335 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 335 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 335 FDA device recalls.

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DateProductReasonClassFirm
Mar 12, 2024 GYROSCAN ACS-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.0T Omni/Stellar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Achieva IT Nova, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Achieva Nova, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN T5-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Omni/Stellar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia 1.5T S, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Feb 15, 2024 DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX syst... If the DIVA touch display generates touch inputs without user interaction, due to possibility of ... Class II Philips North America Llc
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 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 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
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
May 19, 2023 DigitalDiagnost C90, Model No. 712034 and 712035 There is a software login in issue that may prevent the user from logging in. Class II Philips North America Llc
Mar 17, 2023 Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333 Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment ... Class II Philips North America Llc
Mar 9, 2023 DigitalDiagnost C50 1.1-intended for use in generating radiographic images of... If the PM for the telescopic carriage is not performed annually as defined in the Instructions fo... Class II Philips North America Llc
Mar 9, 2023 Philips DigitalDiagnost C50 -intended for use in generating radiographic imag... If the PM for the telescopic carriage is not performed annually as defined in the Instructions fo... Class II Philips North America Llc
Mar 6, 2023 EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Pr... EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r... Class II Philips North America Llc
Mar 6, 2023 EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Produ... EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r... Class II Philips North America Llc
Nov 22, 2022 Philips Upgrade to MR 7700 System, Model Number 782130 Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 22, 2022 Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 78... Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 22, 2022 Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 22, 2022 Philips MR 7700 System, Model Number 782120 Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 22, 2022 Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 78213... Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 21, 2022 Philips Fetal Spiral Electrode-intended for patients requiring fetal heart ra... Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical... Class II Philips North America Llc
Oct 21, 2022 Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Mode... Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a c... Class II Philips North America Llc

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.