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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Date	Product	Reason	Class	Firm
Dec 23, 2021	GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSp...	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 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
Nov 4, 2021	GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"	The firm identified that the Vscan Extend device will not power on because of depleted battery, d...	Class II	GE Healthcare, LLC
Nov 4, 2021	GE Vscan Extend, being sold as "Vscan Extend Console"	The firm identified that the Vscan Extend device will not power on because of depleted battery, d...	Class II	GE Healthcare, LLC
Nov 4, 2021	GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"	The firm identified that the Vscan Extend device will not power on because of depleted battery, d...	Class II	GE Healthcare, LLC
Nov 4, 2021	GE Vscan Extend, being sold as "Vscan Extend Sector USB"	The firm identified that the Vscan Extend device will not power on because of depleted battery, d...	Class II	GE Healthcare, LLC
Nov 4, 2021	GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"	The firm identified that the Vscan Extend device will not power on because of depleted battery, d...	Class II	GE Healthcare, LLC
Nov 4, 2021	GE Vscan Extend, being sold as "Vscan Extend Dual USB"	The firm identified that the Vscan Extend device will not power on because of depleted battery, d...	Class II	GE Healthcare, LLC
Nov 4, 2021	GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"	The firm identified that the Vscan Extend device will not power on because of depleted battery, d...	Class II	GE Healthcare, LLC
Oct 15, 2021	GE Centricity Universal Viewer Zero Footprint Client	There is a potential to display incomplete patient imaging study.	Class II	GE Healthcare, LLC
Aug 26, 2021	SIGNA Premier nuclear magnetic resonance imaging system	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D...	Class II	GE Healthcare, LLC
Aug 26, 2021	Discovery MR750 3.0T nuclear magnetic resonance imaging system	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D...	Class II	GE Healthcare, LLC
Aug 26, 2021	SIGNA Artist nuclear magnetic resonance imaging system	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D...	Class II	GE Healthcare, LLC
Aug 26, 2021	SIGNA Voyager nuclear magnetic resonance imaging system	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D...	Class II	GE Healthcare, LLC
Aug 26, 2021	Discovery MR750w 3.0T nuclear magnetic resonance imaging system	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D...	Class II	GE Healthcare, LLC
Aug 26, 2021	SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D...	Class II	GE Healthcare, LLC
Aug 26, 2021	SIGNA Architect nuclear magnetic resonance imaging system	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D...	Class II	GE Healthcare, LLC
Aug 26, 2021	1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D...	Class II	GE Healthcare, LLC
Aug 26, 2021	Optima MR450w 1.5T nuclear magnetic resonance imaging system	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D...	Class II	GE Healthcare, LLC
Aug 26, 2021	SIGNA Pioneer nuclear magnetic resonance imaging system	Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D...	Class II	GE Healthcare, LLC
Aug 12, 2021	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image proce...	A software anomaly exists in the Centricity Universal Viewer study management feature in which st...	Class II	GE Healthcare, LLC
Aug 6, 2021	Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that di...	Image acquisition failures and synchronization failure with the Centricity Enterprise Archive	Class II	GE Healthcare, LLC
Aug 6, 2021	Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that ...	Image acquisition failures and synchronization failure with the Centricity Enterprise Archive	Class II	GE Healthcare, LLC
Aug 2, 2021	Flow sensors kept as stand-alone user replaceable spare parts for the GEHC an...	The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts t...	Class II	GE Healthcare, LLC
Aug 2, 2021	Flow sensors that may be installed in the following GEHC anesthesia machines:...	The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts t...	Class II	GE Healthcare, LLC
Jun 30, 2021	Revolution CT, Revolution CT ES	The accumulated dose is incorrectly displayed in certain situations. There are two situations tha...	Class II	GE Healthcare, LLC
Jun 30, 2021	The system is intended to produce cross-sectional images of the body by compu...	When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a...	Class II	GE Healthcare, LLC
Jun 30, 2021	Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution ...	The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interve...	Class II	GE Healthcare, LLC
Jun 30, 2021	The system is intended to produce cross-sectional images of the body by compu...	When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a...	Class II	GE Healthcare, LLC
Jun 30, 2021	Revolution Apex, Revolution CT with Apex Edition	The accumulated dose is incorrectly displayed in certain situations. There are two situations tha...	Class II	GE Healthcare, LLC
Jun 30, 2021	The system is intended to produce cross-sectional images of the body by compu...	When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a...	Class II	GE Healthcare, LLC
Jun 24, 2021	AMX Navigate Mobile X-Ray System	An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray ...	Class II	GE Healthcare, LLC
Jun 14, 2021	Revolution EVO, Optima CT660, Optima CT680 CT Systems.	Improperly loaded software options may result in additional X -ray radiation exposure to the pati...	Class II	GE Healthcare, LLC
Jun 4, 2021	SIGNA Voyager, Nuclear Magnetic Resonance Imaging System	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner des...	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner d...	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scan...	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	SIGNA MR380, Nuclear Magnetic Resonance Imaging System	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance sca...	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With ...	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	SIGNA Artist, Nuclear Magnetic Resonance Imaging System	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	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.