BEUDAMED
    FDA Recall Terminated

    Digital Diagnost VE

    Recall: Z-0270-04 · Initiated November 20, 2003

    Recall

    Recall Number
    Z-0270-04
    Event Number
    27839
    Firm
    Philips Medical Systems Sales & Service Region No. America
    FEI Number
    1000524572
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 20, 2003
    Posted
    December 24, 2003
    Terminated
    January 13, 2005
    Address
    22100 Bothell Everett Highway, Bothell, WA, 98041

    Description

    Digital Diagnost VE

    Reason

    The support chain attachment on the detector carriage may fail and cause the counter weights or detector to fall.

    Action

    The firm mailed a recall letter to affected customers on November 20, 2003 notifying them of the problem. The letter states upgrades will be completed by the end of April 2004.

    Distribution

    The firm distributed to medical facilities nationwide.

    Quantity

    70 devices total