BEUDAMED
    FDA Recall Terminated

    SSH-880CV Aplio Artida; System, Diagnostic Ultrasound

    Recall: Z-1498-2011 · Initiated September 28, 2010

    Recall

    Recall Number
    Z-1498-2011
    Event Number
    57303
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 28, 2010
    Posted
    March 3, 2011
    Terminated
    May 2, 2012
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    SSH-880CV Aplio Artida; System, Diagnostic Ultrasound

    Reason

    Toshiba America Medical Systems is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues.

    Action

    Toshiba America Medical Systems (TAMS) sent an URGENT MEDICAL DEVICE CORRECTION letter to consignees via USPS return receipt mail. The letter contained a return reply form that is to be faxed to TAMS at 877-349-3054 as proof of notification. Customers were instructed to share the information with all users and reviewing radiologists as well as clinical engineering or biomedical group at their facility. For questions regarding this recall call 800-421-1968 or 800-521-1968.

    Distribution

    Nationwide Distribution to CA, GA, IA, IL KY, LA, MA, MN, MT, OH, OR, PA, TX, WI, and Puerto Rico.

    Quantity

    40 units