BEUDAMED
    FDA Recall Terminated

    PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems.

    Recall: Z-1997-2010 · Initiated January 5, 2010

    Recall

    Recall Number
    Z-1997-2010
    Event Number
    55544
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 5, 2010
    Posted
    July 13, 2010
    Terminated
    February 29, 2012
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems.

    Reason

    Toshiba America Medical Systems is initiating a field correction on the PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems due to an incorrect sweep direction setting. Images acquired using the endo-cavitary transducer PVT-681MV and cross-sectional images created from these volume images are reversed horizontally on the Aplio XG (SSA-790A) and the Xario XG (

    Action

    Toshiba America Medical Systems (TAMS) will issue notification to consignees via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS as proof of notification. matter. Questions regarding this letter are directed to the firm at (800) 421-1968 or to your local Toshiba representative.

    Distribution

    Nationwide

    Quantity

    27