Browse Device Recalls

969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 969 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 969 FDA device recalls.

Clear
DateProductReasonClassFirm
Apr 19, 2021 Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic... If a certain sequence of events occur, the pdf test report that belongs to one patient will appea... Class II GE Healthcare, LLC
Apr 19, 2021 GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682... The IGS system can experience a single vertical line defect where the vertical line divides and h... Class II GE Healthcare, LLC
Apr 19, 2021 Change Healthcare Enterprise Viewer - Product Usage: intended to be used with... A software defect was identified where the Image Styles defined by presentation states from CHRS ... Class II CHANGE HEALTHCARE CANADA COMPANY
Mar 19, 2021 Centricity Universal Viewer - Product Usage: intended to assist in the viewi... When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workfl... Class II GE Healthcare, LLC
Mar 19, 2021 Revolution CT GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimato... Class II GE Healthcare, LLC
Mar 17, 2021 Change Healthcare Enterprise Viewer Change Healthcare has identified an intermittent software defect which may result in an anchor st... Class II CHANGE HEALTHCARE CANADA COMPANY
Feb 7, 2021 NM/CT 850 Nuclear Medicine / CT Scanners GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause... Class II GE Healthcare, LLC
Feb 7, 2021 NM/CT 870 DR Nuclear Medicine / CT Scanners GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could caus... Class II GE Healthcare, LLC
Feb 7, 2021 NM/CT 860 Nuclear Medicine / CT Scanners GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could caus... Class II GE Healthcare, LLC
Dec 17, 2020 System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex... GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex E... Class II GE Healthcare, LLC
Dec 17, 2020 System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES. GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex E... Class II GE Healthcare, LLC
Dec 10, 2020 Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General N... GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... Class II GE Healthcare, LLC
Dec 10, 2020 GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for genera... GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... Class II GE Healthcare, LLC
Dec 10, 2020 GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for genera... GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... Class II GE Healthcare, LLC
Dec 10, 2020 GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) ... GE Healthcare has become aware of a potential safety issue associated with the improper installat... Class II GE Healthcare, LLC
Dec 10, 2020 Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Dis... GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... Class II GE Healthcare, LLC
Dec 10, 2020 Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 N... GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... Class II GE Healthcare, LLC
Dec 10, 2020 GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for ge... GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... Class II GE Healthcare, LLC
Nov 23, 2020 Revolution CT with Apex Edition CT System - Product Usage: intended for head,... A potential for protocol(s) with unintended patient orientation or scan setting when using Intel... Class II GE Healthcare, LLC
Nov 23, 2020 Revolution CT ES - Product Usage: intended for head, whole body, cardiac and ... A potential for protocol(s) with unintended patient orientation or scan setting when using Intell... Class II GE Healthcare, LLC
Oct 27, 2020 MAC VU360, Electrocardiograph Incorrect patient identification and/or patient demographic errors. Class II GE Healthcare, LLC
Sep 21, 2020 Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product U... There is a potential for a smudge artifact that could be suspect for pathology in some images due... Class II GE Healthcare, LLC
Sep 17, 2020 GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to p... Flow sensors could have damaged tubes in the form of small punctures or cuts. Class II GE Healthcare, LLC
Sep 17, 2020 Flow Sensor Service Part, Catalog 2087640-001-S Flow sensors could have damaged tubes in the form of small punctures or cuts. Class II GE Healthcare, LLC
Sep 17, 2020 Flow Sensor Service Part, Catalog 2096513-001-S Flow sensors could have damaged tubes in the form of small punctures or cuts. Class II GE Healthcare, LLC
Sep 17, 2020 GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to pro... Flow sensors could have damaged tubes in the form of small punctures or cuts. Class II GE Healthcare, LLC
Sep 17, 2020 9100c NXT system - Product Usage: Device is licensed and distributed outside ... Flow sensors could have damaged tubes in the form of small punctures or cuts. Class II GE Healthcare, LLC
Sep 17, 2020 Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia... Flow sensors could have damaged tubes in the form of small punctures or cuts. Class II GE Healthcare, LLC
Sep 17, 2020 Flow Sensor Service Part, Catalog 2089610-001-S Flow sensors could have damaged tubes in the form of small punctures or cuts. Class II GE Healthcare, LLC
Sep 8, 2020 Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnet... Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. Class II GE Healthcare, LLC
Sep 8, 2020 System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. Class II GE Healthcare, LLC
Sep 8, 2020 System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. Class II GE Healthcare, LLC
Sep 8, 2020 System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. Class II GE Healthcare, LLC
Sep 8, 2020 System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. Class II GE Healthcare, LLC
Aug 25, 2020 Change Healthcare Radiology Solutions 14.0 Software defect which may potentially result in one or more images missing in a study Class II CHANGE HEALTHCARE CANADA COMPANY
Aug 14, 2020 NM/CT 860, SPECT/CT Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 14, 2020 Discovery 670 DR Model # H3100BT Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 14, 2020 NM 830 Model # H3910AC Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 14, 2020 NM/CT 870 CZT Model # H3906CW Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 14, 2020 NM/CT 870 DR Model # H3100AS Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 14, 2020 Discovery NM670 Pro Model # H3100XB Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 14, 2020 Discovery NM 630 Model # H3101RH Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 14, 2020 NM/CT 850 Model Number: H3907AD Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 6, 2020 Merge PACS Measurements done on the Merge PACS generated MPR s may have incorrect measurements. Class II Merge Healthcare, Inc.
Jul 14, 2020 CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocesso... The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an ... Class II GE Healthcare, LLC
Jun 22, 2020 CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi... CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if ... Class II GE Healthcare, LLC
May 18, 2020 CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCA... The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/... Class II GE Healthcare, LLC
May 8, 2020 Merge Healthcare Merge Application Server Software Release and Merge Healthca... An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score c... Class II Merge Healthcare, Inc.
May 8, 2020 The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images o... GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referr... Class II Ge Healthcare
Apr 28, 2020 Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer. Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmenta... 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.