BEUDAMED
    FDA Recall Terminated

    Optimus 30

    Recall: Z-1084-05 · Initiated February 24, 2005

    Recall

    Recall Number
    Z-1084-05
    Event Number
    33411
    Firm
    Philips Ultrasound, Inc.
    FEI Number
    3019216
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 24, 2005
    Posted
    November 8, 2005
    Terminated
    September 27, 2010
    Address
    22100 Bothell-Everett Hwy. P.O. Box 3003, Bothell, WA, 98041-3003

    Description

    Optimus 30

    Reason

    Systems do not comply with the labeling performance standards.

    Action

    On/about 2/24/04 the firm''s representatives began visiting sites to apply appropriate labeling. The firrm''s representatives will test units to verify compliance.

    Distribution

    Devices were distributed to 38 medical centers and hospitals throughout the US.

    Quantity

    44 units