BEUDAMED
    FDA Recall Terminated

    Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems.

    Recall: Z-0097-04 · Initiated October 10, 2003

    Recall

    Recall Number
    Z-0097-04
    Event Number
    27477
    Firm
    Philips Medical Systems Sales & Service Region No. America
    FEI Number
    1000524572
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 10, 2003
    Posted
    July 20, 2004
    Terminated
    February 13, 2006
    Address
    22100 Bothell Everett Highway, Bothell, WA, 98041

    Description

    Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems.

    Reason

    The thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall.

    Action

    The firm issued a letter dated October 10, 2003 to all affected customers. The suspension will be upgraded by field service personnel starting October 24, 2003.

    Distribution

    The firm distributes to hospitals and medical centers.

    Quantity

    570 units