BEUDAMED
    FDA Recall Terminated

    B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887

    Recall: Z-1140-2008 · Initiated January 24, 2008

    Recall

    Recall Number
    Z-1140-2008
    Event Number
    46394
    Firm
    B & K Medical Systems, Inc.
    FEI Number
    1000305740
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 24, 2008
    Posted
    June 10, 2008
    Terminated
    June 23, 2008
    Address
    250 Andover St, Wilmington, MA, 01887-1048

    Description

    B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887

    Reason

    Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.

    Action

    B-K Medical issued letter notification on 1/23/08 to accounts via Fed Ex, advising them not to use the unit until a representative can inspect and exchange, if unit is found defective. Instructions are also provided to continue use of the device with a sterile cover until site visit.

    Distribution

    USA Distribution: MA, MI, PA, TX, and OR.

    Quantity

    7