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
43
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 43 (9%) 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.

101–125 of 475

  • ModerateFDA (Devices)·Z-2022-2021·2021-07-14

    GE Healthcare Revolution CT user interface fails to confirm scan group addition

    The GE Healthcare Revolution CT system's user interface fails to update and confirm when scan group names are added using certain characters. This configuration defect requires a software fix to ensure proper scan group setup.

    Product
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs includ
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2021-2021·2021-07-14

    GE Revolution CT User Interface Issue with Scan Groups

    The GE Revolution CT user interface may fail to confirm when scan group names are added if they contain characters other than letters, numbers, or spaces.

    Product
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs inclu
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2023-2021·2021-07-14

    GE Revolution CT scanner user interface fails to confirm scan group names

    The GE Revolution CT imaging system's user interface fails to update and confirm when scan group names contain characters other than letters, numbers, or spaces, potentially causing user uncertainty during scan setup.

    Product
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either witho
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1900-2021·2021-07-07

    CT Systems Recall: Improperly Loaded Software May Increase X-Ray Radiation

    GE Healthcare is recalling Revolution EVO, Optima CT660, and Optima CT680 CT Systems due to improperly loaded software that may result in additional X-ray radiation exposure to patients.

    Product
    Revolution EVO, Optima CT660, Optima CT680 CT Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1927-2021·2021-06-30

    Cardiac assessment system may display test reports in wrong patient records

    GE Healthcare's Case Cardiac Assessment System and CardioSoft diagnostic application may display one patient's cardiac test report in another patient's medical record under certain conditions. No patient injuries have been reported.

    Product
    Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2021·2021-06-23

    GE Healthcare X-Ray Systems Affected by Display Image Distortion Defect

    GE Healthcare interventional x-ray imaging systems can develop a display defect that splits and distorts live monitor images into two unequal parts. The defect affects 139 devices with worldwide distribution.

    Product
    GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1547-2021·2021-05-19

    GE Healthcare Recalls NM/CT 870 DR Scanners for Radiation Exposure Shift

    GE Healthcare is recalling NM/CT 870 DR scanners because a specific workflow may cause a shift in CT radiation exposure range, potentially requiring patient re-scans.

    Product
    NM/CT 870 DR Nuclear Medicine / CT Scanners
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1545-2021·2021-05-19

    GE Healthcare Recalls NM/CT 850 Scanners Due to Radiation Exposure Shift

    GE Healthcare is recalling NM/CT 850 scanners because a specific workflow may cause a 5cm shift in CT radiation exposure, potentially requiring patient re-scans.

    Product
    NM/CT 850 Nuclear Medicine / CT Scanners
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1546-2021·2021-05-19

    GE Healthcare Recalls NM/CT 860 Scanners Due to Radiation Exposure Shift

    GE Healthcare is recalling NM/CT 860 scanners because a specific protocol may cause a 5cm shift in radiation exposure, potentially requiring patient re-scans.

    Product
    NM/CT 860 Nuclear Medicine / CT Scanners
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2021·2021-05-12

    GE Healthcare Recalls Centricity Universal Viewer for Patient Data Mismatch Risk

    GE Healthcare is recalling 112 units of Centricity Universal Viewer software because a specific configuration may display comparison exams from the wrong patient.

    Product
    Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2021·2021-02-24

    GE Healthcare Recalls Revolution CT Systems Due to Table Pinch Protector Defect

    GE Healthcare is recalling Revolution CT and Revolution CT ES systems because damaged or missing table pinch protectors may expose sharp screws, posing a laceration risk.

    Product
    System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2021·2021-02-24

    GE Healthcare Recalls Revolution CT Systems Due to Table Pinch Protector Issue

    GE Healthcare is recalling 96 Revolution CT systems because a damaged or missing table pinch protector may expose sharp screws, posing a laceration risk.

    Product
    System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2021·2021-02-17

    GE Healthcare Precision 600FP Monitor Suspension Recall

    GE Healthcare is recalling 113 Precision 600FP systems due to a potential monitor suspension defect that could cause injury.

    Product
    GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0856-2021·2021-01-20

    GE Healthcare Recalls Discovery NM 630 and 830 Nuclear Medicine Cameras

    GE Healthcare is recalling 81 Discovery NM 630 and 830 units due to loose rotor bearing screws that could release a bearing.

    Product
    Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0857-2021·2021-01-20

    GE Healthcare Recalls Nuclear Medicine Systems Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling 52 nuclear medicine systems worldwide because loose rotor bearing screws caused a bearing to release in one field unit.

    Product
    Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseas
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0858-2021·2021-01-20

    GE Healthcare Recalls Optima NM/CT 640 Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling seven Optima NM/CT 640 units because loose rotor bearing screws caused a bearing release in one field unit.

    Product
    Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0853-2021·2021-01-20

    GE Healthcare Recalls NM/CT 850 Systems Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling 24 NM/CT 850 systems because loose rotor bearing screws caused a bearing to release in one field unit.

    Product
    GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0854-2021·2021-01-20

    GE Healthcare Recalls 12 NM/CT 860 Systems Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling 12 NM/CT 860 systems because loose rotor bearing screws caused a bearing release in one field unit.

    Product
    GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0855-2021·2021-01-20

    GE Healthcare Recalls NM/CT 870 CZT Systems Due to Loose Rotor Screws

    GE Healthcare is recalling 12 NM/CT 870 CZT systems because loose rotor bearing screws may cause a bearing to release.

    Product
    GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0695-2021·2020-12-30

    GE Healthcare Recalls Three Revolution CT Systems for Protocoling Errors

    GE Healthcare is recalling three Revolution CT systems due to a potential for unintended patient orientation or scan settings when using Intelligent Protocoling.

    Product
    Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0694-2021·2020-12-30

    GE Healthcare Recalls Two Revolution CT ES Units for Protocoling Error

    GE Healthcare is recalling two Revolution CT ES units due to a potential for unintended patient orientation or scan settings when using Intelligent Protocoling.

    Product
    Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.