BEUDAMED
    FDA Recall Terminated

    Bucky Diagnost FS Part number 9890-010-83651

    Recall: Z-0268-04 · Initiated November 18, 2003

    Recall

    Recall Number
    Z-0268-04
    Event Number
    27827
    Firm
    Philips Medical Systems Sales & Service Region No. America
    FEI Number
    1000524572
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 18, 2003
    Posted
    December 24, 2003
    Terminated
    April 11, 2005
    Address
    22100 Bothell Everett Highway, Bothell, WA, 98041

    Description

    Bucky Diagnost FS Part number 9890-010-83651

    Reason

    Support chain attachment on the Bucky carriage may fail and cause the counter weights or X-ray tube to fall.

    Action

    The firm mailed a letter to their customers on November 18, 2003 stating upgrades will begin November 14, 2003.

    Distribution

    The firm distributed to three medical facilities in Florida, New York and California.

    Quantity

    3 units