BEUDAMED
    FDA Recall Terminated

    Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01)

    Recall: Z-0865-05 · Initiated May 6, 2005

    Recall

    Recall Number
    Z-0865-05
    Event Number
    32064
    Firm
    Philips Ultrasound, Inc.
    FEI Number
    3019216
    Product Code
    DPW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 6, 2005
    Posted
    June 3, 2005
    Terminated
    May 21, 2008
    Address
    22100 Bothell-Everett Hwy. P.O. Box 3003, Bothell, WA, 98041-3003

    Description

    Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01)

    Reason

    The acoustic display of Mechanical Index and Thermal Index is inaccurate - two transducers may exceed limits for acoustic intensity and MI.

    Action

    On May 6, 2005 the firm mailed a letter, via return receipt requested, to customers. The letter advised of the problem, and provided instructions to create new low power presets. The letter also advised that software would be issued on/before November 2005.

    Distribution

    The units were distributed worldwide. Domestic distribution included hospitals and medical centers.

    Quantity

    1225 units