BEUDAMED
    137 results · 40ms · Sources: EU EUDAMED, US FDA

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    GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code IYO·November 4, 2021

    1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·February 18, 2022

    1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·February 18, 2022

    System, Tomography Computed Emmission

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code KPS·November 30, 2018

    SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·June 4, 2021

    SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·June 4, 2021

    Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·June 4, 2021

    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 include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code JAK·June 30, 2021

    9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code BSZ·September 17, 2020

    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.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code KPS·December 10, 2020

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code BSZ·May 27, 2022

    Lunar iDXA bone densitometer

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code KGI·December 3, 2019

    Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code KGI·December 3, 2019

    Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code KPS·February 12, 2019

    B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code MHX·September 11, 2018