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.

126–150 of 475

  • HighFDA (Devices)·Z-0312-2021·2020-11-11

    GE Datex-Ohmeda Avance CS2 Anesthesia System Recalled for Damaged Flow Sensors

    GE Healthcare is recalling 88 Avance CS2 Anesthesia Systems because flow sensors may have damaged tubes with small punctures or cuts.

    Product
    GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0314-2021·2020-11-11

    GE Healthcare Recalls 9100c NXT Systems Due to Flow Sensor Defects

    GE Healthcare is recalling 37 9100c NXT systems because flow sensors may have damaged tubes with small punctures or cuts.

    Product
    9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0311-2021·2020-11-11

    GE Healthcare Recalls Aestiva/5 MRI Anesthesia Systems Due to Flow Sensor Defect

    GE Healthcare is recalling two Aestiva/5 MRI Anesthesia Systems because flow sensors may have damaged tubes with small punctures or cuts.

    Product
    Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0306-2021·2020-11-04

    GE Healthcare Recalls CT Scanners Due to Potential Image Artifacts

    GE Healthcare is recalling 64 CT scanners worldwide because incorrect settings may cause smudge artifacts that could be mistaken for pathology.

    Product
    Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0127-2021·2020-10-28

    GE Healthcare Recalls MRI Systems Due to Potential Electrical Arc Flash

    GE Healthcare is recalling 30 MRI systems due to a potential electrical arc flash hazard within the Power Gradient & RF cabinet.

    Product
    System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0128-2021·2020-10-28

    GE Healthcare Recalls MRI Systems Due to Electrical Arc Flash Risk

    GE Healthcare is recalling 30 MRI systems worldwide due to a potential electrical arc flash hazard within the power cabinet.

    Product
    System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0130-2021·2020-10-28

    GE Healthcare Recalls MRI Systems Due to Electrical Arc Flash Risk

    GE Healthcare is recalling 30 MRI systems worldwide due to a potential electrical arc flash hazard within the Power Gradient & RF Cabinet.

    Product
    System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0129-2021·2020-10-28

    GE Healthcare Recalls MRI Systems Due to Electrical Arc Flash Risk

    GE Healthcare is recalling 30 MRI systems worldwide due to a potential electrical arc flash hazard within the power cabinet.

    Product
    System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0131-2021·2020-10-28

    GE Healthcare Recalls PET/MR Imagers Due to Electrical Arc Flash Risk

    GE Healthcare is recalling specific PET/MR imager models due to a potential electrical arc flash hazard within the Power Gradient & RF Cabinet.

    Product
    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2995-2020·2020-09-30

    GE Healthcare Recalls NM 830 Medical Detectors Due to Loose Screws

    GE Healthcare is recalling 25 NM 830 detectors because rotor bearing screws were found loose. The devices are distributed in the US and internationally.

    Product
    NM 830 Model # H3910AC
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-2997-2020·2020-09-30

    GE Healthcare Recalls Discovery NM670 Pro Due to Loose Screws

    GE Healthcare is recalling nine Discovery NM670 Pro units because rotor bearing screws were found loose on the detector.

    Product
    Discovery NM670 Pro Model # H3100XB
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-2883-2020·2020-09-02

    GE Healthcare Recalls CARESCAPE R860 Ventilators Due to Oxygen Sensor Issue

    GE Healthcare is recalling 2,277 CARESCAPE R860 ventilators because a potential oxygen sensor issue may cause inaccurate FiO2 readings.

    Product
    CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2750-2020·2020-08-12

    GE Healthcare Recalls CARESCAPE ONE Monitors Due to Alarm Failure Risk

    GE Healthcare is recalling 8,414 CARESCAPE ONE patient monitors because they may fail to provide visual and audible alarms for Ventricular Fibrillation when docked to specific host monitors.

    Product
    CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2020·2020-07-01

    GE Healthcare Recalls CARESCAPE Patient Data Modules Due to False Alarms

    GE Healthcare is recalling CARESCAPE Patient Data Modules because they may display false flat-line ECGs and asystole alarms when used with an AED.

    Product
    CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-001-045915 2042084-001-215164 2042084-001-078474 2042084-0
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2235-2020·2020-06-24

    GE Healthcare Recalls Giraffe OmniBed Incubators Due to Oxygen Display Error

    GE Healthcare is recalling Giraffe OmniBed infant incubators equipped with Servo Oxygen modules because they may deliver a different oxygen level than displayed.

    Product
    Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2020·2020-06-24

    GE Healthcare Recalls Giraffe Incubators with Servo Oxygen Module

    GE Healthcare is recalling Giraffe Incubators with Servo Oxygen modules because they may deliver different oxygen levels than displayed.

    Product
    Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2258-2020·2020-06-10

    GE Healthcare Recalls Nuclear Medicine Systems Due to Software Defect

    GE Healthcare is recalling 526 Nuclear Medicine systems because outdated software caused a patient's finger to be injured during an automatic unload process.

    Product
    System, Tomography Computed Emmission
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2259-2020·2020-06-10

    GE Healthcare Recalls Nuclear Medicine Systems Due to Software Defect

    GE Healthcare is recalling 526 Discovery NM 530c systems because outdated software caused a patient finger injury during an automatic unload process.

    Product
    System, Tomography Computed Emmission
    Category
    Medical Device
    Distribution
    40 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.