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.

451–475 of 475

  • HighFDA (Devices)·Z-0606-2013·2013-01-02

    GE T-Piece Resuscitation Circuits Recalled for Pressure Deficiency

    GE Healthcare is recalling T-Piece Neonatal Patient Circuit Kits because they cannot achieve maximum Peak Inspiratory Pressure during pre-use checks.

    Product
    GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Ci
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0560-2013·2012-12-26

    GE Healthcare Recalls Advantage Workstation Software Due to Vessel Label Mismatch

    GE Healthcare is recalling specific Advantage Workstation software versions due to a potential vessel label mismatch and a measurement tool refresh issue that may impact patient safety.

    Product
    Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET or
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0524-2013·2012-12-26

    GE Healthcare Recalls Carescape Patient Data Module Software

    GE Healthcare is recalling Carescape Patient Data Module units with v2.0 software due to two issues that may impact patient care.

    Product
    GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-0494-2013·2012-12-26

    GE Healthcare Recalls Dash Patient Monitors Due to NBP Cycling Issue

    GE Healthcare is recalling 119,260 Dash 3000/4000/5000 patient monitors due to a potential issue where Custom Automatic NBP Measurement cycling may stop unexpectedly.

    Product
    GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0448-2013·2012-12-05

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

    GE Healthcare is recalling Optima XR220amx and XR200amx mobile X-ray systems due to a software issue on the product interface.

    Product
    GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0450-2013·2012-12-05

    GE Healthcare Recalls Mobile X-Ray Units Due to Software Issue

    GE Healthcare is recalling Optima XR200amx and XR22Oamx mobile X-ray units due to a software issue on the interface.

    Product
    GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0449-2013·2012-12-05

    GE Healthcare Recalls Mobile X-Ray Systems Due to Software Issue

    GE Healthcare is recalling Optima XR220amx and XR200amx mobile X-ray systems due to a software issue on the interface.

    Product
    GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2013·2012-11-28

    GE Healthcare Recalls Mobile Radiographic Imaging Systems Due to Firmware Issue

    GE Healthcare is recalling specific mobile radiographic imaging systems due to a firmware issue affecting technique accuracy as mandated by regulations.

    Product
    GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2013·2012-11-28

    GE Healthcare Recalls Mobile Radiographic Units Due to Firmware Issue

    GE Healthcare is recalling specific mobile radiographic units due to a firmware issue affecting technique accuracy as mandated by federal regulations.

    Product
    GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0197-2013·2012-11-28

    GE Healthcare Recalls Mobile Radiographic Systems Due to Firmware Issue

    GE Healthcare is recalling specific mobile radiographic systems due to a firmware issue affecting technique accuracy.

    Product
    GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0200-2013·2012-11-28

    GE Healthcare Recalls Mobile Radiographic Imaging Systems Due to Firmware Issue

    GE Healthcare is recalling Brivo XR 285 and Optima XR series mobile radiographic systems due to a firmware issue affecting technique accuracy.

    Product
    GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0114-2013·2012-10-31

    GE Healthcare Recalls innova 3100-IQ Mobile X-ray Systems Due to Filter Failure

    GE Healthcare is recalling 199 innova 3100-IQ mobile X-ray systems in the US due to a potential failure of the spectral filter mechanism inside the collimator.

    Product
    GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2013·2012-10-31

    GE Healthcare recalls innova mobile X-ray systems due to filter failure

    GE Healthcare is recalling 199 innova mobile X-ray systems in the US due to a potential failure of the spectral filter mechanism inside the collimator.

    Product
    GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0113-2013·2012-10-31

    GE Healthcare Recalls innova 3100 Mobile X-ray Systems Due to Filter Failure

    GE Healthcare is recalling 199 innova 3100 mobile X-ray systems due to a potential failure of the spectral filter mechanism inside the collimator.

    Product
    GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2013·2012-10-31

    GE Seno Advantage Workstation Recalled for Incorrect Magnification Measurements

    GE Healthcare is recalling Seno Advantage Workstations because measurement values may be incorrect for magnification images from non-GE digital mammography systems.

    Product
    GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a vari
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0121-2013·2012-10-31

    GE Healthcare Recalls Discovery NM/CT 670 and NM 630 Systems

    GE Healthcare is recalling 210 Discovery NM/CT 670 and NM 630 systems due to a potential safety issue where the table pallet may contact the detector during operation.

    Product
    GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0125-2013·2012-10-31

    GE Healthcare Recalls Seno Advantage 2.2 Workstations Due to Scale Factor Errors

    GE Healthcare is recalling 12 Seno Advantage 2.2 workstations because inaccurate scale factor annotations may lead to miscalculation of image sizes, potentially impacting patient safety.

    Product
    GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2012·2012-09-19

    GE Healthcare Recalls Optima XR220amx Mobile X-Ray Units Due to Software Issue

    GE Healthcare is recalling 254 Optima XR220amx mobile X-ray units in the US because a software defect allows exposures without displaying technique factors.

    Product
    Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2012·2012-09-19

    GE Healthcare Recalls Optima XR200amx Mobile X-Ray Units Due to Software Issue

    GE Healthcare is recalling 254 Optima XR200amx mobile X-ray units in the US because a software defect allows exposures without displaying technique factors.

    Product
    Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2376-2012·2012-09-19

    GE Healthcare Recalls Innova 2121IQ and 3131IQ X-ray Systems

    GE Healthcare is recalling Innova 2121IQ and 3131IQ systems due to a potential loss of imaging mode requiring a restart.

    Product
    GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interven
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-2203-2012·2012-08-22

    GE Healthcare Advantage Workstations Recalled for Incorrect Aorta Measurements

    GE Healthcare is recalling Advantage Workstations with Advanced Vessel Analysis due to incorrect aorta measurements and potential issues with PET data loading.

    Product
    GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2015-2012·2012-07-25

    GE Healthcare Recalls Invasive Blood Pressure Care Cables

    GE Healthcare is recalling 279 invasive blood pressure care cables due to a faulty O-ring that prevents correct blood pressure monitoring.

    Product
    GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1993-2012·2012-07-25

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

    GE Healthcare is recalling Optima XR200 and XR220 mobile X-ray systems because a software issue affects the visual indication required by regulations.

    Product
    GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1960-2012·2012-07-18

    GE Healthcare Recalls CT/PET Fusion Software Due to Image Alignment Issues

    GE Healthcare is recalling CT/PET Fusion software versions 4.0, 4.1, and 4.2 because fused CT and PET images may be incorrectly aligned.

    Product
    GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tom
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1787-2012·2012-06-27

    GE Healthcare Recalls Aestiva 7900 Anesthesia Machines Due to Missing Interlock

    GE Healthcare is recalling eight Aestiva 7900 anesthesia machines because a missing interlock slide may allow two vaporizers to deliver agents simultaneously.

    Product
    GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
    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.