BEUDAMED
    FDA Recall Terminated

    Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C

    Recall: Z-0099-04 · Initiated October 10, 2003

    Recall

    Recall Number
    Z-0099-04
    Event Number
    27485
    Firm
    Philips Medical Systems Sales & Service Region No. America
    FEI Number
    1000524572
    Product Code
    EHD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 10, 2003
    Posted
    July 20, 2004
    Terminated
    January 13, 2005
    Address
    22100 Bothell Everett Highway, Bothell, WA, 98041

    Description

    Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C

    Reason

    The cable carrier and cables may fall after repeat collisions with OR lamps, radiation shields or other supported accessories.

    Action

    The firm sent a letter dated, October 10, 2003 indicating the firm''s service representatives will upgrade the cable carrier by mounting a safety catch inside the cable carrier.

    Distribution

    The firm distributes to hospitals and medical centers nationwide.

    Quantity

    536 units