BEUDAMED
    FDA Recall Terminated

    Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.

    Recall: Z-0546-04 · Initiated January 27, 2004

    Recall

    Recall Number
    Z-0546-04
    Event Number
    28184
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 27, 2004
    Posted
    July 20, 2004
    Terminated
    July 13, 2005
    Address
    2441 Michelle Dr, Tustin, CA, 92781

    Description

    Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.

    Reason

    Software anomally causes image slices to be in incorrect order.

    Action

    Firm sent letters to customers 1/28/2004 which explains how to avoid the adverse event and announces that a software fix is going to be made available.

    Distribution

    NV, CO, OH, PA, CA, TN, FL, TX, OK, OR, NY, NJ and Puerto Rico.

    Quantity

    24