BEUDAMED
    FDA Recall Terminated

    Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc. A diagnostic ultrasound system.

    Recall: Z-2897-2011 · Initiated October 1, 2010

    Recall

    Recall Number
    Z-2897-2011
    Event Number
    57856
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 1, 2010
    Posted
    July 29, 2011
    Terminated
    April 20, 2012
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc. A diagnostic ultrasound system.

    Reason

    Toshiba America Medical Systems, Inc. is initiating a field correction on the Aplio Artida Ultrasound Diagnostic System because the panel operation for the Aplio Artida may become disabled (i.e., system may hang up) when processing to display patient information (heart rate, time, VCP counter, ect.).

    Action

    Toshiba America Medical Systems, Inc. sent out an "Urgent Medical Device Correction" dated December 21, 2010 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were notified that Toshiba will issue a field modification to correct the software, and if the problem occurs, they were instructed to shutdown the system holding down the power supply button for 5 seconds for 5 seconds and then restart the system. A form to send back to Toshiba is included. For questions on this recall call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.

    Distribution

    Worldwide Distribution: (USA) Nationwide distribution including the states of MD, OH, PA, NY, MA, GA, AL, TX, IL, WI, IA, MN, KY, MT, OR, LA, and CA; and the country of Puerto Rico.

    Quantity

    46 units