The Recall Desk

Manufacturer

GE Healthcare, LLC

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

What the numbers show

Total
475
Critical
8
Severe
67
Most recent
2026-04-08

Of the 475 recalls from GE Healthcare, LLC we have scored against our rubric, 8 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 67 (14%) are Severe.

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 475

  • 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-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-0606-2022·2022-02-16

    GE Healthcare MRI Systems Recalled for Inadequate Cryogen Ventilation

    GE Healthcare SIGNA HFO/I MR Systems may have cryogen ventilation systems that do not meet venting requirements. Approximately 17,228 systems are affected nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0608-2022·2022-02-16

    GE Healthcare MRI systems recalled over improper cryogen ventilation

    GE Healthcare is recalling MRI systems with potentially non-compliant cryogen ventilation. Over 17,228 superconducting magnetic resonance imaging devices may have cryogen venting systems that fail to meet FDA requirements.

    Product
    GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR 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-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-0599-2022·2022-02-16

    GE Healthcare MRI superconducting magnets recalled for cryogen ventilation defects

    GE Healthcare is recalling MR superconducting magnets used in SIGNA Voyager MRI systems due to cryogen ventilation systems that may not meet venting requirements. The recall affects 17,228 devices.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging 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
  • 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-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-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-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-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-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-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
  • 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-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
    19 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
    19 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
    19 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
    19 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
    19 states
  • 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
    19 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
    19 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

GE HealthCare

American multinational medical technology company

Country
United States
Founded
2004

Official website

Source: Wikidata (Q1152374), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.