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-0598-2022·2022-02-16
GE Healthcare MRI Systems with Potentially Non-Compliant Cryogen Ventilation Systems
GE Healthcare has recalled approximately 17,228 MRI systems due to cryogen ventilation systems that may not meet required venting standards. The issue affects systems distributed nationwide and internationally.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0616-2022·2022-02-16
GE Healthcare MR Superconducting Magnets Cryogen Ventilation System Defect
GE Healthcare is recalling 17,228 superconducting magnetic resonance imaging systems due to potential cryogen ventilation system defects that may not meet safety venting requirements.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0612-2022·2022-02-16
GE Healthcare MRI superconducting magnets recalled for cryogen ventilation defect
GE Healthcare is recalling 17,228 MRI superconducting magnets that may have improper cryogen ventilation systems. The defect could fail to properly vent cryogenic materials in the SIGNA 3.0T MR System.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0591-2022·2022-02-16
GE Healthcare MRI magnets recalled for cryogen ventilation defect
GE Healthcare is recalling 17,228 MRI system magnets with potential cryogen ventilation defects. No injuries have been reported.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0610-2022·2022-02-16
GE Healthcare MRI Superconducting Magnets: Cryogen Ventilation System Defect
GE Healthcare is recalling 17,228 MRI systems because the cryogen ventilation system may not meet venting requirements. The company is providing field corrections to ensure proper ventilation.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0617-2022·2022-02-16
GE Healthcare MRI systems recalled for cryogenic ventilation defect
GE Healthcare MRI systems may have cryogenic ventilation systems that do not meet venting requirements. The recall affects 17,228 devices distributed nationwide and globally. Healthcare facilities should contact GE Healthcare for corrective actions.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus), nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0603-2022·2022-02-16
GE Healthcare MRI systems recalled for cryogen ventilation defect
GE Healthcare is recalling certain MRI systems because the cryogen ventilation system does not meet venting requirements. The defect could affect safe operation of the MRI magnet.
Product
GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibran
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-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-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-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-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
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-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
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-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-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-0138-2022·2021-10-27
GE Healthcare SIGNA Voyager MRI System Recall for Missing Image Slices
GE Healthcare is recalling the SIGNA Voyager nuclear magnetic resonance imaging system due to a software issue that can cause missing slices in 3D volume images, potentially creating gaps in anatomical information.
Product
SIGNA Voyager nuclear magnetic resonance imaging system
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0136-2022·2021-10-27
GE Discovery MR750 MRI System May Produce Incomplete Diagnostic Images
GE Healthcare's Discovery MR750 3.0T MRI system may not capture all required image slices under certain conditions, resulting in gaps in diagnostic 3D images. Five devices are affected.
Product
Discovery MR750 3.0T 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-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