BEUDAMED
    FDA Recall Terminated

    Philips BV300 Mobile X-Ray System

    Recall: Z-0526-03 · Initiated September 27, 2002

    Recall

    Recall Number
    Z-0526-03
    Event Number
    25248
    Firm
    Philips Medical Systems
    FEI Number
    1000524572
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2002
    Posted
    February 1, 2003
    Terminated
    January 12, 2005
    Address
    22100 Bothell Everett Highway, Bothell, WA, 98041

    Description

    Philips BV300 Mobile X-Ray System

    Reason

    The C-bow support can bend and break allowing C-arm to fall from support

    Action

    The firm issued a letter dated 9/27/02 to their customers. The letter advised of the problem and that a service representative will visit to inspect unit and correct.

    Distribution

    The firm distributed to hospitals, x-ray centers and medical centers throughout the U.S.

    Quantity

    229 devices