BEUDAMED
    FDA Recall Terminated

    Philips MX8000 IDT CT Scanner System, 10 & 16 slice images.

    Recall: Z-0786-04 · Initiated March 8, 2004

    Recall

    Recall Number
    Z-0786-04
    Event Number
    27979
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 8, 2004
    Posted
    July 20, 2004
    Terminated
    October 29, 2008
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Philips MX8000 IDT CT Scanner System, 10 & 16 slice images.

    Reason

    The CT couch may move downward to its lower limit without command.

    Action

    The firm contacted their Field Service Personnel by letter on 3/8/2004. The letter instructs the field personnel to immediately install the corrective firmware kits (from Siemens) on all affected units in the field.

    Distribution

    The systems were installed at medical facilities located nationwide and worldwide.

    Quantity

    385 units