BEUDAMED
    FDA Recall Terminated

    Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps. and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate. blood vessels, and musculoskeletal regions of the body.

    Recall: Z-1188-2017 · Initiated January 20, 2017

    Recall

    Recall Number
    Z-1188-2017
    Event Number
    76378
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 20, 2017
    Posted
    February 10, 2017
    Terminated
    September 24, 2019
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps. and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate. blood vessels, and musculoskeletal regions of the body.

    Reason

    Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn.

    Action

    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter GEHC Ref# 60913 Dated January 20, 2017. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Worldwide Distribution- US (nationwide) including states of: CA, DC, IL, MN, MO, NY, SC, TX, WI, WV; and countries of: Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and Uruguay.

    Quantity

    60