BEUDAMED
    FDA Recall Terminated

    Magnetic Resonance Imaging Device

    Recall: Z-0910-06 · Initiated February 21, 2006

    Recall

    Recall Number
    Z-0910-06
    Event Number
    35087
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 21, 2006
    Posted
    May 31, 2006
    Terminated
    February 16, 2012
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    Magnetic Resonance Imaging Device

    Reason

    The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.

    Action

    The recalling firm plans to notify their customers of this recall/soft ware correction during a scheduled visit to be conducted at each customer site by a Hitachi Field Service Technician. During the visit, the necessary corrective software will be installed. The visits/corrections began on: 2/21/06.

    Distribution

    Nationwide

    Quantity

    1129