BEUDAMED
    FDA Recall Terminated

    Aplio 80; SSA-770A; software version 5.5r002

    Recall: Z-1172-2010 · Initiated November 12, 2007

    Recall

    Recall Number
    Z-1172-2010
    Event Number
    52832
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 12, 2007
    Posted
    March 19, 2010
    Terminated
    April 18, 2012
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    Aplio 80; SSA-770A; software version 5.5r002

    Reason

    Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A; software version 1.0 and later, because the product does not meet the Safety Standard requirements.

    Action

    Toshiba America Medical Systems (TAMS) has issued a Field Modification Instruction notification to all of its customers about the affected devices. The correct software will be administered through TAMS' representatives. Reimbursement for the modification will be given upon receipt of the reimbursement claim invoice.

    Distribution

    Nationwide Distribution

    Quantity

    94 units