BEUDAMED
    FDA Recall Terminated

    Convex Array Transducer used with B-K Ultrasound Scanners Model number: 8667

    Recall: Z-0856-06 · Initiated March 16, 2006

    Recall

    Recall Number
    Z-0856-06
    Event Number
    34900
    Firm
    B & K Medical Systems, Inc.
    FEI Number
    1000305740
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2006
    Posted
    May 9, 2006
    Terminated
    October 12, 2006
    Address
    250 Andover St, Wilmington, MA, 01887-1048

    Description

    Convex Array Transducer used with B-K Ultrasound Scanners Model number: 8667

    Reason

    Due to a problem with calibration, the device can produce up to 50% elevated acoustic output and up to 2 degrees higher surface temperature

    Action

    BK Medical notified customers by letter on 4/10/06 via FedEx advising user of the problem and scheduling the software correction by a Service representative visit .

    Distribution

    CA,CT, FL, MD, ME, MN, MS, NY, OH, RI, SD, TX, VA

    Quantity

    28 units