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Browse Device Recalls

474 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 474 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 474 FDA device recalls.

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DateProductReasonClassFirm
Feb 28, 2014 GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 C... GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE ... Class II GE Healthcare, LLC
Feb 14, 2014 GE Healthcare Optima CT580/Discovery CT590RT scanners running software versio... GE Healthcare has recently become aware of a potential safety issue due to a software issue assoc... Class II GE Healthcare, LLC
Feb 13, 2014 GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.... GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patien... Class II GE Healthcare, LLC
Feb 7, 2014 GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Du... Potential safety issue related to unintended radial detector motion, which may occur during patie... Class II GE Healthcare, LLC
Feb 7, 2014 GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended u... Potential safety issue related to unintended radial detector motion, which may occur during patie... Class II GE Healthcare, LLC
Feb 7, 2014 Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera... Potential safety issue related to unintended radial detector motion, which may occur during patie... Class II GE Healthcare, LLC
Jan 20, 2014 GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital ... GE Healthcare has recently become aware of a software issue associated with patient selection fro... Class II GE Healthcare, LLC
Dec 27, 2013 GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARES... GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE ... Class II GE Healthcare, LLC
Dec 20, 2013 CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intende... There is a potential for communication loss associated with the F5-01 Frame when connected to CAR... Class II GE Healthcare, LLC
Dec 16, 2013 SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthc... GE Healthcare has recently become aware of a potential safety issue which affects all Patient Da... Class II GE Healthcare, LLC
Dec 12, 2013 GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging sys... GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D,... Class II GE Healthcare, LLC
Dec 11, 2013 GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova... GE Healthcare has become aware of a potential safety issue involving the innova systems. The Inno... Class II GE Healthcare, LLC
Dec 5, 2013 GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intende... Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ... Class II GE Healthcare, LLC
Dec 5, 2013 GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: Th... Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ... Class II GE Healthcare, LLC
Dec 5, 2013 SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthc... Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ... Class II GE Healthcare, LLC
Nov 27, 2013 GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM)... GE Healthcare has recently become aware of a potential safety issue due to intermittent failure o... Class II GE Healthcare, LLC
Nov 27, 2013 GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port... GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash... Class II GE Healthcare, LLC
Nov 20, 2013 GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery ... GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection... Class II GE Healthcare, LLC
Nov 15, 2013 GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imagi... GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imagi... Class II GE Healthcare, LLC
Nov 8, 2013 Video Monitor Suspensions that may be on the following Fluoroscopic and Radio... Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws t... Class II GE Healthcare, LLC
Nov 7, 2013 GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiograph... There exists a software issue associated with patient selection from the worklist on the Optima X... Class II GE Healthcare, LLC
Oct 25, 2013 GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo ... GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan proce... Class II GE Healthcare, LLC
Oct 11, 2013 HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40,... GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings as... Class II GE Healthcare, LLC
Oct 11, 2013 GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasoun... GE became aware of a potential safety issue due to a system slow down and system lock up associat... Class II GE Healthcare, LLC
Oct 9, 2013 GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Inten... There is an issue with the Manual Film Composer feature on some CT products. There is an opportu... Class II GE Healthcare, LLC
Oct 1, 2013 GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-... Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... Class I GE Healthcare, LLC
Oct 1, 2013 GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: T... Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... Class I GE Healthcare, LLC
Oct 1, 2013 GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe S... Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... Class I GE Healthcare, LLC
Sep 19, 2013 AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESH... GE Healthcare has recently become aware of a potential safety issue due to the image orientation ... Class II GE Healthcare, LLC
Sep 19, 2013 Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Dispos... GE Healthcare has recently become aware of a potential safety issue due to air leakage associated... Class I GE Healthcare, LLC
Sep 16, 2013 GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume ... GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance ... Class I GE Healthcare, LLC
Aug 30, 2013 GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is inte... GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device... Class II GE Healthcare, LLC
Aug 28, 2013 GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Inte... GE Healthcare has recently become aware of a potential safety issue involving unresponsive button... Class I GE Healthcare, LLC
Aug 16, 2013 GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100I... GE Healthcare has become aware of a potential safety issue involving missing screws in the overhe... Class II GE Healthcare, LLC
Aug 13, 2013 GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 ... GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on... Class II GE Healthcare, LLC
Aug 7, 2013 GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be u... GE has recently become aware of a potential safety issue due to the incorrect calculation of the ... Class II GE Healthcare, LLC
Jul 29, 2013 Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The D... GE Healthcare has recently become aware of a potential safety issue involving the pre-operative c... Class II GE Healthcare, LLC
Jun 19, 2013 GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The a... GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS... Class II GE Healthcare, LLC
Jun 13, 2013 Discovery NM 630, dual detector free-geometry integrated nuclear imaging syst... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Cam... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Brivo NM615, is an all-purpose, single detector integrated nuclear imaging sy... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intend... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging sy... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is inten... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
May 14, 2013 Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or ... GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 ab... Class II GE Healthcare, LLC
May 9, 2013 GE Healthcare, PET VCAR. PET VCAR application software is affected if inst... GE Healthcare has recently become aware of a potential safety issue with respect to the automated... Class II GE Healthcare, LLC
May 2, 2013 GE Healthcare, Precision 500D Product Usage: The Precision 500D is design... GE Healthcare has recently become aware of a potential safety issue involving the overhead Video ... Class II GE Healthcare, LLC
Apr 10, 2013 The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybr... GE Healthcare has recently become aware of an incident where the wrong part of the patient body w... Class II GE Healthcare, LLC
Apr 9, 2013 GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the fol... GE Healthcare has recently become aware of a potential safety issue due to non-unique series iden... Class II GE Healthcare, 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.