BEUDAMED
    FDA Recall Terminated

    Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.

    Recall: Z-1068-2013 · Initiated November 14, 2012

    Recall

    Recall Number
    Z-1068-2013
    Event Number
    64673
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 14, 2012
    Posted
    April 8, 2013
    Terminated
    April 8, 2013
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92780-7047

    Description

    Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.

    Reason

    Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal.

    Action

    Toshiba American Medical Systems Inc. sent a Urgent Medical Device Correction letter dated November 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer was informed a New software to prevent the occurrence of this issue will be installed on your system. Toshiba Service Representative will contact you for an appointment to install the New Software on your Aquilion One System. Please fax the return reply form to (877) 349-3054. We thank you for your urgent attention to this matter. If you have any further questions regarding this letter please call (800) 521-1968.

    Distribution

    Distributed in the state of MD.

    Quantity

    1 unit