BEUDAMED
    FDA Recall Terminated

    TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.

    Recall: Z-1067-2013 · Initiated November 30, 2011

    Recall

    Recall Number
    Z-1067-2013
    Event Number
    64667
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 30, 2011
    Posted
    April 8, 2013
    Terminated
    June 17, 2013
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92780-7047

    Description

    TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.

    Reason

    The firm initiated this recall due to a potential software issue. The DLP (Dose Length Product) value may be displayed incorrectly when the vHP option is used.

    Action

    Toshiba sent "URGENT: MEDICAL DEVICE CORRECTION" letters to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter contained a return reply form that is to be faxed to TAMS for retention. Contact the firm at (800) 421-1968 for questions relating to this letter.

    Distribution

    Nationwide Distribution including the states of WA, OH, CA, TX, WV, IL, AZ, CA, WI, ME, WI, NC, FL, MT, and HI.

    Quantity

    23 units