Manufacturer

GE Healthcare, LLC

105 recalls in our database name GE Healthcare, LLC as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 105

HighFDA (Devices)·Z-0602-2022·2022-02-16
GE Healthcare MRI systems recalled for cryogen ventilation system defect
GE Healthcare Discovery MR450 MRI systems may have cryogen ventilation systems that do not meet required venting standards. The recall affects approximately 17,228 devices distributed in the U.S. and internationally.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0604-2022·2022-02-16
GE Healthcare MR Superconducting Magnets Recalled for Ventilation Defect
GE Healthcare recalled 17,228 superconducting magnets, a component of SIGNA 1.5T MR systems, due to a cryogen ventilation system that may not meet venting requirements. Systems are distributed nationwide and internationally.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0596-2022·2022-02-16
GE Healthcare MRI Systems Recalled for Potential Cryogen Ventilation Defect
GE Healthcare is recalling approximately 17,228 SIGNA Creator and Explorer MRI systems due to potential defects in their cryogen ventilation systems that may not meet required venting standards.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0594-2022·2022-02-16
GE Healthcare MRI Systems Recalled for Inadequate Cryogen Ventilation
GE Healthcare is recalling MRI superconducting magnets with cryogen ventilation system defects not meeting safety requirements. The recall affects 17,228 devices distributed across the US and internationally.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0605-2022·2022-02-16
GE Healthcare MR system magnets recalled due to cryogen ventilation defect
GE Healthcare is recalling 17,228 MR superconducting magnet components due to a cryogen ventilation system that may not meet required venting specifications.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Technology, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0593-2022·2022-02-16
GE Healthcare MRI Systems Cryogen Ventilation System Defect Recall
GE Healthcare is recalling Discovery MR750w 3.0T MRI systems due to cryogen ventilation systems that may not meet FDA venting requirements. Approximately 17,228 devices were affected.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0601-2022·2022-02-16
GE Healthcare MRI Cryogen Ventilation System Defect Recall
GE Healthcare is recalling 17,228 MRI systems due to a potential defect in the cryogen ventilation system that may not meet venting requirements. This Class II recall affects systems distributed nationwide and internationally.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0621-2022·2022-02-16
GE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect
GE Healthcare is recalling 17,228 MRI superconducting magnets due to a potential cryogen ventilation system defect. The systems may not meet required venting specifications.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0524-2022·2022-02-02
GE Vscan Extend ultrasound device recalled for power-on failure due to battery depletion
GE Healthcare is recalling the Vscan Extend ultrasound device because it will not power on when the battery is depleted. This occurs when the device is not turned off before battery removal or is connected to a computer without AC power.
Product
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-0520-2022·2022-02-02
GE Vscan Extend Ultrasound Device Battery Power Failure Recall
GE Healthcare recalls the Vscan Extend portable ultrasound device because the battery may become depleted and prevent the device from powering on if not turned off before battery removal or when used without AC power.
Product
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-0518-2022·2022-02-02
GE Vscan Extend ultrasound console fails to power on when battery is depleted
GE Healthcare is recalling the Vscan Extend ultrasound console due to battery depletion that prevents powering on. The problem occurs when the battery depletes if the device is not turned off before battery removal or is connected to a computer without AC power.
Product
GE Vscan Extend, being sold as "Vscan Extend Console"
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-0522-2022·2022-02-02
GE Vscan Extend Ultrasound System Recalled for Battery Power Failure
GE Healthcare is recalling the Vscan Extend portable ultrasound device due to battery power failure. The device may not power on when the battery is depleted, particularly if not turned off before battery removal or when connected to a computer without AC power.
Product
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-0523-2022·2022-02-02
GE Vscan Extend portable ultrasound may not power on due to battery depletion
GE Healthcare is recalling GE Vscan Extend portable ultrasound devices that may fail to power on if not turned off before battery removal or when connected to a computer without AC power.
Product
GE Vscan Extend, being sold as "Vscan Extend Sector USB"
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-0519-2022·2022-02-02
GE Vscan Extend Ultrasound Device May Fail to Power On
GE Vscan Extend portable ultrasound devices may not power on due to battery depletion caused by improper device handling. The device must be properly turned off before removing the battery or disconnecting from power sources.
Product
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-0521-2022·2022-02-02
GE Vscan Extend Ultrasound Devices May Not Power On Due to Battery Depletion
GE Healthcare is recalling Vscan Extend portable ultrasound devices that may fail to power on due to battery depletion when the device is not turned off before battery removal or before connecting without AC power.
Product
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
Category
Medical Device
Distribution
50 states
HighFDA (Devices)·Z-0329-2022·2021-12-08
GE Centricity Medical Imaging Software May Display Incomplete Patient Studies
GE Healthcare recalled versions of Centricity Universal Viewer Zero Footprint Client software due to a potential defect that could display incomplete patient imaging studies. No injuries have been reported.
Product
GE Centricity Universal Viewer Zero Footprint Client
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0242-2022·2021-12-01
GE Healthcare CT Systems Display Incorrect Radiation Doses During Certain Exams
GE Healthcare's Revolution CT systems may display accumulated radiation doses up to 100 times higher than the actual dose delivered during certain interventional imaging procedures. The displayed value is incorrect, but the actual dose patients receive is accurate.
Product
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0137-2022·2021-10-27
GE SIGNA MRI Systems Software Issue Causes Missing Image Slices
GE Healthcare's SIGNA Creator and SIGNA Explorer MRI systems may produce incomplete 3D images due to missing slices in software version DV29.1. Missing anatomical information could impact diagnostic accuracy.
Product
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0132-2022·2021-10-27
MRI System Software Defect Causes Missing Image Slices
GE Healthcare is recalling 11 SIGNA Premier MRI systems. Under certain conditions, software versions RX29.1 and RX27.3 can cause missing slices in 3D imaging, creating gaps in anatomical data clinicians use for diagnosis.
Product
SIGNA Premier nuclear magnetic resonance imaging system
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0133-2022·2021-10-27
MRI System Software Defect May Cause Missing Anatomical Image Data
GE Healthcare's SIGNA Architect MRI system may fail to generate complete image slices under certain software conditions, resulting in gaps within 3D volume images that could affect diagnostic imaging integrity.
Product
SIGNA Architect nuclear magnetic resonance imaging system
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0140-2022·2021-10-27
MRI system software may produce incomplete 3D images
GE Healthcare is recalling Optima MR450w 1.5T MRI systems due to a software issue in version DV29.1 that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.
Product
Optima MR450w 1.5T nuclear magnetic resonance imaging system
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0139-2022·2021-10-27
GE SIGNA Artist MRI System May Produce Incomplete Image Scans
GE Healthcare recalls 18 SIGNA Artist MRI systems with a software defect that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.
Product
SIGNA Artist nuclear magnetic resonance imaging system
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0135-2022·2021-10-27
Discovery MR750w 3.0T MRI: Missing Image Slices in 3D Volume
GE Healthcare recalls the Discovery MR750w 3.0T MRI system. Under certain software conditions, image slices may be missing, creating gaps in 3D diagnostic images.
Product
Discovery MR750w 3.0T nuclear magnetic resonance imaging system
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0134-2022·2021-10-27
GE SIGNA Pioneer MRI Recall for Missing Image Slices
GE Healthcare is recalling 5 SIGNA Pioneer MRI systems where a software issue can cause missing image slices in 3D volume scans. This may lead to diagnostic gaps.
Product
SIGNA Pioneer nuclear magnetic resonance imaging system
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0141-2022·2021-10-27
MRI System Recall: GE Healthcare SIGNA HDxt Missing Image Slices
GE Healthcare is recalling the 1.5T SIGNA HDxt MR System due to a software issue that may cause missing slices in 3D volume images. Three devices distributed across the United States and internationally are affected.
Product
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
Category
Medical Device
Distribution
18 states