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Browse Device Recalls

79 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 79 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 79 FDA device recalls.

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DateProductReasonClassFirm
Dec 21, 2018 Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging ... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging Sy... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resona... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Multiva 1.5T 8 R5 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Im... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Reson... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Im... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance I... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia Elition X, Model Number 781358. Nuclear Magnetic Resonance Imaging ... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance I... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resona... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging Sy... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonanc... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imagi... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 3, 2018 Ingenia Elition S, Ingenia Elition X During automatic tabletop movement, pressing and holding the Stop Table button may lead to an u... Class II Philips Medical Systems Nederlands
Nov 30, 2018 Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 Philips has discovered through customer complaints and internal testing an intermittent electroni... Class II Philips Medical Systems Nederlands
May 1, 2018 OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. ... The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and... Class II Philips Medical Systems Nederlands
May 1, 2018 OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708... The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and... Class II Philips Medical Systems Nederlands
Mar 26, 2018 MultiDim Eleva 708032 As a multifunctional universal imaging application... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional univers... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional unive... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional unive... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 MultiDiagnost Eleva 708036 As a multifunctional universal imaging applicat... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 708033 URODiagnost As a multifunctional universal imaging application syst... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Jun 23, 2016 Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product... Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increase... Class II Philips Medical Systems Nederlands

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.