BEUDAMED
    FDA Recall Terminated

    Aplio XG model SSA-790A Aplio XG (SSA-790A) is a premium-class diagnostic ultrasound system incorporating state-of-the-art technologies. It is provided with the highest level of image quality and operability (reflecting the XG (next Generation) in its name), and can be used with ease for research as well as for routine clinical studies.

    Recall: Z-2981-2011 · Initiated June 2, 2010

    Recall

    Recall Number
    Z-2981-2011
    Event Number
    55941
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 2, 2010
    Posted
    August 10, 2011
    Terminated
    April 20, 2012
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    Aplio XG model SSA-790A Aplio XG (SSA-790A) is a premium-class diagnostic ultrasound system incorporating state-of-the-art technologies. It is provided with the highest level of image quality and operability (reflecting the XG (next Generation) in its name), and can be used with ease for research as well as for routine clinical studies.

    Reason

    Toshiba America Medical Systems Inc (TAMS) is initiating a field correction on the the Aplio XG model SSA-790A because it did not meet the requirement of clause 15b, IEC60601-1 which requires that the residual voltage shall not exceed 60V after 1 second from taking off the AC plug.

    Action

    Toshiba America Medical Systems (TAMS) sent an "URGENT:MEDICAL DEVICE CORRECTION' letter dated June 2, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to be careful not to touch the contacts or prongs on the AC plug within two seconds after unplugging the system from a wall socket. This precaution is to be adhered to until a Toshiba Service Representative replaces the power supply. Customers are to complete and return a Customer Reply Form and fax to 877-349-3054. Customers with questions regarding the notification should contact the Director of Regulatory Affairs at (800) 421-1968 or call their local Toshiba Representative at (800) 521-1968.

    Distribution

    Nationwide Distribution

    Quantity

    78