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.

376–400 of 475

  • ModerateFDA (Devices)·Z-0725-2014·2014-01-22

    GE Healthcare Recalls Mobile X-ray Systems Due to Software Display Issue

    GE Healthcare is recalling 1,027 Optima XR220amx and XR200amx mobile X-ray systems due to a software issue that may cause patient exams to display incorrectly.

    Product
    GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0648-2014·2014-01-15

    GE Healthcare Recalls Patient Data Modules Due to Heat Buildup Risk

    GE Healthcare is recalling 17,444 Patient Data Modules used with SOLAR 8000 and Transport Pro monitors. The recall addresses a potential safety issue where fluid ingress can cause heat buildup.

    Product
    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2014·2013-12-25

    GE Healthcare Recalls Multi Absorber Original Devices Due to Air Leakage

    GE Healthcare is recalling Multi Absorber Original, Disposable devices due to a potential safety issue involving air leakage associated with the CO2 Multi Absorber.

    Product
    Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2014·2013-12-18

    GE Healthcare Patient Monitors Recalled for Incorrect ECG Filter Settings

    GE Healthcare is recalling specific patient monitors because they may apply an incorrect ECG filter setting if impedance respiration is enabled at startup.

    Product
    HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2014·2013-11-27

    GE Healthcare Recalls SPECT Imaging Systems Due to Potential Patient Contact Hazard

    GE Healthcare is recalling four models of nuclear medicine and CT imaging systems because the detector may contact a patient's elbow during specific SPECT scans.

    Product
    GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ functio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0373-2014·2013-11-27

    GE Vivid E9 Ultrasound Systems Recalled for Software Lockup

    GE Healthcare is recalling 710 Vivid E9 ultrasound systems worldwide due to a software defect that can cause the system to slow down and lock up during critical procedures.

    Product
    GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array trans
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0270-2014·2013-11-20

    GE Healthcare Recalls AW Workstations Due to Image Orientation Error

    GE Healthcare is recalling AW VolumeShare and AW Server software due to a potential safety issue where images may display in the wrong orientation after rotation.

    Product
    AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a varie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2014·2013-10-23

    GE PET Discovery 610 and 710 Recalled for Image Series UID Conflict

    GE Healthcare is recalling PET scanners because a software issue may cause different image series to share the same ID, potentially leading to incorrect image display.

    Product
    GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0012-2014·2013-10-23

    GE Healthcare X-ray Systems Recalled for Loose Power Assist Handle Bolts

    GE Healthcare is recalling 810 X-ray systems because internal bolts on the power assist handle may loosen or fall out, potentially causing the handle to stick in the ON position.

    Product
    GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to per
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0009-2014·2013-10-23

    GE Healthcare Recalls Anesthesia Devices Due to Tidal Volume Overdelivery Risk

    GE Healthcare is recalling specific anesthesia devices because they may deliver excessive tidal volume in a specific ventilation mode, posing a risk of harm to patients.

    Product
    GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0021-2014·2013-10-23

    GE Healthcare Recalls X-ray Systems Due to Missing Monitor Screws

    GE Healthcare is recalling specific X-ray imaging systems because missing screws in the overhead video monitor suspension could create a safety hazard.

    Product
    GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2014·2013-10-23

    GE Healthcare Recalls Ventilators and Anesthesia Machines with Unresponsive Buttons

    GE Healthcare is recalling 911 ventilators and anesthesia machines because manufacturing defects may cause display buttons to fail, preventing access to menu functions.

    Product
    GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0023-2014·2013-10-23

    GE Optima CT660 Recalled for Potential Series UID Generation Error

    GE Healthcare is recalling Optima CT660 scanners because the DMPR and Screen Save functions may generate duplicate Series UIDs, potentially causing PACS systems to combine patient series incorrectly.

    Product
    GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2291-2013·2013-10-09

    GE Healthcare Recalls MR Scanners Due to Exposed Foam on End Bells

    GE Healthcare is recalling specific MRI scanners because yellow foam on the end bells may extend past the covers. The foam itself is not hazardous, but it may absorb fluids.

    Product
    GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa¿ MR 750 System is indicated for use as a diagnostic imaging device to produce axial,
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2266-2013·2013-10-02

    GE Healthcare Recalls MRI Scanners Due to Non-Unique Series Identifiers

    GE Healthcare is recalling specific MRI scanners because they may generate non-unique series identifiers in image headers, which can cause data association errors when exported to PACS systems.

    Product
    GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2257-2013·2013-09-25

    GE Healthcare Recalls Seno Advantage Workstations Due to Patient Mismatch Risk

    GE Healthcare is recalling 179 Seno Advantage workstations because a software issue may cause patient mismatch without a warning message, potentially impacting patient safety.

    Product
    GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing, filming
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2013·2013-09-25

    GE Healthcare Recalls CARESCAPE Monitor B650 Due to Potential Issues

    GE Healthcare is recalling CARESCAPE Monitor B650 units due to potential issues. No injuries or illnesses have been reported.

    Product
    GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2013·2013-09-25

    GE Healthcare Recalls CARESCAPE Monitor B850 for Alarm Priority Issue

    GE Healthcare is recalling 636 CARESCAPE Monitor B850 units due to a software issue that may cause incorrect alarm priorities when managed via the iCentral network.

    Product
    GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2013·2013-09-25

    GE Healthcare recalls READY View fMRI software due to incorrect maps

    GE Healthcare is recalling READY View software because it may compute and display incorrect fMRI activation maps.

    Product
    GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2253-2013·2013-09-25

    GE Healthcare Recalls Discovery IGS 730 X-Ray Systems for Boot Failure

    GE Healthcare is recalling four Discovery IGS 730 Cardiovascular X-Ray Imaging Systems due to a software error that may prevent the system from booting.

    Product
    GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2161-2013·2013-09-18

    GE Healthcare Recalls Tec 6 Anesthesia Vaporizers Due to Leak Detection Issue

    GE Healthcare is recalling Tec 6 and Tec 6 Plus anesthesia vaporizers because the pre-operative leak test may fail to detect leaks caused by seal wear.

    Product
    Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2013·2013-09-04

    GE Healthcare Recalls Patient Data Modules Due to Signal Noise

    GE Healthcare is recalling CARESCAPE Patient Data Modules because movement of the ECG connector can cause signal noise, potentially reducing the device's ability to detect arrhythmias.

    Product
    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patien
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2013·2013-09-04

    GE Healthcare Recalls TRAM Modules Due to ECG Signal Noise

    GE Healthcare is recalling TRAM Modules because movement of the ECG connector causes signal noise, which may reduce the accuracy of ECG, respiration, and arrhythmia monitoring.

    Product
    GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2013·2013-09-04

    GE Ultrasound ViewPoint 6 Recalled for Incorrect Pulsatility Index Calculations

    GE Healthcare is recalling 225 units of the ViewPoint 6 ultrasound system because it may incorrectly calculate venous flow measurements, potentially leading to false high-risk diagnoses for trisomy.

    Product
    GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2013·2013-09-04

    GE Healthcare Recalls Dash Patient Monitors Due to Signal Noise

    GE Healthcare is recalling Dash 3000, 4000, and 5000 patient monitors because movement of the ECG connector can cause intermittent noise on ECG and respiration waveforms, potentially reducing detection performance.

    Product
    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.
    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.