BEUDAMED
    FDA Recall Terminated

    Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

    Recall: Z-0094-04 · Initiated September 15, 2003

    Recall

    Recall Number
    Z-0094-04
    Event Number
    27429
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 15, 2003
    Posted
    November 6, 2003
    Terminated
    October 29, 2008
    Address
    595 Miner Rd, Cleveland, OH, 44143

    Description

    Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

    Reason

    Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.

    Action

    The firm notified their affected consignees by letter on 9/15/2003. The customers were informed how to avoid the problem until a software upgrade is installed on the units.

    Distribution

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

    Quantity

    1,334 units installed