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.

326–350 of 475

  • HighFDA (Devices)·Z-1915-2016·2016-06-15

    GE Revolution CT Patient Table Recalled for Unintended Motion Risk

    GE Healthcare is recalling Revolution CT Patient Tables because the cradle can descend on its own, posing a crushing risk to large patients.

    Product
    GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2015·2014-12-24

    GE Healthcare Recalls Innova 4100IQ Fluoroscopic Imaging Systems

    GE Healthcare is recalling six Innova 4100IQ fluoroscopic systems due to a defect that may cause loss of real-time imaging or gantry motion.

    Product
    Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0452-2015·2014-12-24

    GE Healthcare Recalls Discovery IGS 740 Imaging Systems Due to Loss of Function

    GE Healthcare is recalling Discovery IGS 740 systems because they may lose real-time imaging or motion capabilities due to electromagnetic sensitivity.

    Product
    Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0451-2015·2014-12-24

    GE Healthcare Recalls Innova IGS 540 Imaging Systems Due to Motion Loss

    GE Healthcare is recalling 10 Innova IGS 540 systems because they may lose real-time imaging or gantry motion due to electromagnetic sensitivity.

    Product
    Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0184-2015·2014-11-19

    GE Healthcare Infinia Nuclear Medicine Systems Recalled for Loose Fasteners

    GE Healthcare is recalling Infinia nuclear medicine systems because loose fasteners could cause a portion of the system to fall onto a patient during a scan.

    Product
    GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0186-2015·2014-11-19

    GE Discovery NM/CT 670 Imaging System Recalled for Loose Fasteners

    GE Healthcare is recalling 255 Discovery NM/CT 670 systems because loose fasteners may cause a portion of the system to fall onto patients during scans.

    Product
    Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare profession
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0188-2015·2014-11-19

    GE Optima NM/CT 640 Recalled for Loose Camera Fasteners

    GE Healthcare is recalling 29 Optima NM/CT 640 systems because loose fasteners could cause the camera to fall onto a patient during a scan.

    Product
    Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2015·2014-11-19

    GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems

    GE Healthcare is recalling 147 Discovery NM 630 nuclear imaging systems to update maintenance procedures and prevent loose fasteners from causing parts to fall on patients.

    Product
    Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, locali
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2015·2014-11-19

    GE Healthcare Recalls Brivo NM615 Nuclear Imaging Systems Due to Loose Fasteners

    GE Healthcare is recalling 22 Brivo NM615 nuclear imaging systems because loose fasteners could cause a portion of the system to fall onto a patient during a scan.

    Product
    Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ. Product Usage: The Brivo NM 615 is an emission computed tomography system inten
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0185-2015·2014-11-19

    GE Healthcare Recalls Varicam and VG Hawkeye Nuclear Medicine Devices

    GE Healthcare is recalling 478 nuclear medicine imaging devices because loose fasteners could cause a portion of the system to fall onto a patient during a scan.

    Product
    GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2015·2014-10-08

    GE Healthcare Precision 500D X-ray Systems Recalled for Missing Screws

    GE Healthcare is recalling Precision 500D X-ray systems because missing screws may cause the overhead video monitor to detach from the tray assembly.

    Product
    GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2617-2014·2014-09-17

    GE Healthcare Recalls CARESCAPE Respiratory Modules Due to O2 Sensor Failure

    GE Healthcare is recalling 748 CARESCAPE respiratory modules and Airway Gas Options due to a potential O2 sensor component failure.

    Product
    CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCA
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2291-2014·2014-08-27

    GE Healthcare Recalls Discovery XR656P/N Wall Stand Systems Due to Hook Failure

    GE Healthcare is recalling 334 Discovery XR656P/N wall stand systems because nylon hooks supporting the detector may fail, causing the detector to fall.

    Product
    GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.
    Category
    Medical Device
    Distribution
    31 states
  • SevereFDA (Devices)·Z-2068-2014·2014-07-30

    GE Healthcare Recalls DateX-Ohmeda S/5 Airway Modules Due to CO2 Measurement Failure

    GE Healthcare is recalling DateX-Ohmeda S/5 Single-Width Airway Modules and E-miniC accessories because a CO2 detector failure may cause incorrect low readings, potentially impairing clinical decision-making for ventilated patients.

    Product
    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2085-2014·2014-07-30

    GE Healthcare CARESCAPE Patient Monitors Recalled for Data Loss

    GE Healthcare is recalling CARESCAPE B850, B650, and B450 patient monitors because the Patient Data Module may fail to communicate, causing partial loss of monitoring parameters.

    Product
    GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2014·2014-07-30

    GE Healthcare Recalls CARESCAPE Monitor B650 Due to Sound Loss

    GE Healthcare is recalling CARESCAPE Monitor B650 units because they may lose alarm sounds when an external display is connected via a USB extender with an active hub.

    Product
    GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1988-2014·2014-07-09

    GE Healthcare Recalls Proteus XR/a X-ray Systems Due to Collimator Fall Risk

    GE Healthcare is recalling Proteus XR/a and Revolution XR/d X-ray systems due to a collimator installation error that caused a serious patient injury.

    Product
    GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1989-2014·2014-07-09

    GE Healthcare Recalls Revolution XR/d X-ray Systems Due to Collimator Fall Risk

    GE Healthcare is recalling Revolution XR/d digital radiographic systems because a collimator installation error during maintenance could cause the device to fall and injure patients.

    Product
    GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose dia
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1808-2014·2014-06-25

    GE Healthcare Compact Airway Modules Recalled for Pump Failure Risk

    GE Healthcare is recalling Compact Airway Modules because a loose screw may cause pump failure, leading to loss of respiratory gas monitoring.

    Product
    GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1706-2014·2014-06-11

    GE Healthcare Recalls Kenex Ceiling Suspended Radiation Shields and Lamps

    GE Healthcare is recalling Kenex ceiling suspended radiation shields and surgical lamps due to improper installation. A reported incident involved a shield falling from the ceiling.

    Product
    Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers: E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2014·2014-05-28

    GE Healthcare Recalls NeuroMuscular Transmission Modules for Inaccurate Readings

    GE Healthcare is recalling 1,794 NeuroMuscular Transmission Modules because they may display inaccurate muscle relaxation levels when used with ElectroSensors.

    Product
    GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2014·2014-05-07

    GE Healthcare Recalls CardiacVX Software Due to Inaccurate Flow Values

    GE Healthcare is recalling CardiacVX and CardiacVX Flow software because it may report flow values higher than actual. The recall affects 101 units distributed worldwide.

    Product
    GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the revi
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1533-2014·2014-05-07

    GE Healthcare Recalls MRI Scanners Due to Cradle Release Malfunction

    GE Healthcare is recalling 1,548 MRI scanners because a malfunctioning cradle release mechanism could delay or impede patient egress from the system.

    Product
    GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnosti
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1480-2014·2014-04-30

    GE Healthcare Recalls MR Scanners Due to Gradient Coil Overheating Risk

    GE Healthcare is recalling 1,546 MRI scanners worldwide because gradient coil connections may loosen, causing overheating, smoke, and potential fire.

    Product
    GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.
    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.