BEUDAMED
    FDA Recall Terminated

    Optima 1.5T MR430s MR Scanner, a diagnostic imaging device

    Recall: Z-1928-2016 · Initiated May 9, 2016

    Recall

    Recall Number
    Z-1928-2016
    Event Number
    74215
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 9, 2016
    Posted
    June 8, 2016
    Terminated
    July 11, 2018
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Optima 1.5T MR430s MR Scanner, a diagnostic imaging device

    Reason

    The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.

    Action

    GE Healthcare sent an " Urgent Medical Device Correction" letter dated May 9, 2016, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Detail, Product Correction & Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    US: AL, AZ, CA, CO, FL, ID, IL, IA,ME, NE, NV,NH, NJ, NY, NC, OH, PA, SC, SD, TN, TX, UT,VA, WA, WI. OUS: Argentina Australia Austria Brazil Canada Chile Colombia Denmark Egypt Finland France Germany Greece Hong Kong Iceland Italy Japan Korea (Republic of) Kuwait Malaysia Netherlands Norway Peru Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland Ukraine United Arab Emirates United Kingdom

    Quantity

    101