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
Jul 15, 2022 (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity ... Inaccurate Distance and Area measurements with use of Global Stack viewport. Class II GE Healthcare, LLC
Jun 24, 2022 SIGNA Premier magnetic resonance scanner, model 5748519. Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise durin... Class II GE Healthcare, LLC
Jun 14, 2022 Centricity PACS Software Version 7.0 SP0.0.4.7 The Event Notification Manager (ENM) functionality for certain products does not process notifica... Class II GE Healthcare, LLC
Jun 8, 2022 GE Centricity Universal Viewer Zero Footprint. To view, communicate, proces... Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footpr... Class II GE Healthcare, LLC
Jun 2, 2022 Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT170... As a result of unclear guidance in the service manual, the table can drop during a specific servi... Class II GE Healthcare, LLC
Jun 1, 2022 GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Ava... There is a potential reversal of the O2 and air cylinder pressure transducer connections. Class I GE Healthcare, LLC
May 27, 2022 GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-... The base of the anesthesia system can have a crack and could potentially fracture resulting in a ... Class II GE Healthcare, LLC
May 10, 2022 CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-00... The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component fa... Class II GE Healthcare, LLC
Apr 28, 2022 Centricity PACS RA1000 Potential for Distance and Area measurements to display inaccurate measurement values when perfor... Class II GE Healthcare, LLC
Apr 28, 2022 Centricity Cardiology CA1000 Potential for Distance and Area measurements to display inaccurate measurement values when perfor... Class II GE Healthcare, LLC
Apr 28, 2022 Centricity Enterprise Web Potential for Distance and Area measurements to display inaccurate measurement values when perfor... Class II GE Healthcare, LLC
Apr 28, 2022 Centricity Universal Viewer Zero Footprint Client Potential for Distance and Area measurements to display inaccurate measurement values when perfor... Class II GE Healthcare, LLC
Apr 28, 2022 Centricity Radiology RA600 Potential for Distance and Area measurements to display inaccurate measurement values when perfor... Class II GE Healthcare, LLC
Apr 25, 2022 Field replacement back up batteries distributed on or after April 1, 2019 for... Backup batteries can fail earlier than their estimated life. Class II GE Healthcare, LLC
Apr 25, 2022 Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufac... Backup batteries can fail earlier than their estimated life. Class II GE Healthcare, LLC
Apr 18, 2022 Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 ... Insufficient battery backup power resulting in premature shutdown of the ventilator when not conn... Class I GE Healthcare, LLC
Apr 18, 2022 Replacement back up batteries distributed on or after April 1, 2019, for CARE... Insufficient battery backup power resulting in premature shutdown of the ventilator when not conn... Class I GE Healthcare, LLC
Mar 16, 2022 MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 310101... Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test i... Class II GE Healthcare, LLC
Mar 4, 2022 GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier,... During the de-installation of an MR system magnet, if all rigging and hardware that attach to the... Class II GE Healthcare, LLC
Feb 18, 2022 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile... There is potential for the images to be flipped left to right. Class II GE Healthcare, LLC
Feb 18, 2022 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System There is potential for the images to be flipped left to right. Class II GE Healthcare, LLC
Feb 18, 2022 SIGNA Excite 3T. Magnetic Resonance Imaging System There is potential for the images to be flipped left to right. Class II GE Healthcare, LLC
Feb 18, 2022 Signa 1.5T TwinSpeed Magnetic Resonance Imaging System There is potential for the images to be flipped left to right. Class II GE Healthcare, LLC
Jan 28, 2022 GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF... If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare Contou... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare Discov... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare Discov... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with E... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vec... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthon... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare Discov... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infini... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T S... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... Class II GE Healthcare, LLC
Dec 23, 2021 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... 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.