BEUDAMED
    FDA Recall Terminated

    MRP-7000, AIRIS Magnetic Resonance Imaging Systems

    Recall: Z-1105-06 · Initiated March 17, 2006

    Recall

    Recall Number
    Z-1105-06
    Event Number
    35103
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 17, 2006
    Posted
    June 10, 2006
    Terminated
    November 13, 2008
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    MRP-7000, AIRIS Magnetic Resonance Imaging Systems

    Reason

    Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a possible patient mis-diagnosis.

    Action

    On 3/17/2006, the firm began conducting a survey of all afftected customer sites in order to determine if corrected software has been installed on the unit(s) at each customer location. If the corrected software has not been installed, the firm''s Field Service Engineers will install software upgrades as necessary.

    Distribution

    Nationwide-The devices were distributed to consignees located througout the United States.

    Quantity

    283