BEUDAMED
    FDA Recall Terminated

    Datex-Ohmeda Cardiocap/5 Patient Monitors

    Recall: Z-0143-04 · Initiated October 17, 2003

    Recall

    Recall Number
    Z-0143-04
    Event Number
    27599
    Firm
    Datex-Ohmeda Inc One Ohmeda
    FEI Number
    2183066
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 17, 2003
    Posted
    July 20, 2004
    Terminated
    November 15, 2005
    Address
    Dr. Box 7550, Madison, WI, 53707

    Description

    Datex-Ohmeda Cardiocap/5 Patient Monitors

    Reason

    Datex-Ohmeda Cardiocap/5 Patient Monitors have bracket pins which do not adequately secure them to their optional mounting stand so the monitors may fall.

    Action

    Recall letters dated October 15, 2003 were sent to the consignees on 10/17/03. The letters request that the consignees order service kits to correct the units and use the kits to make the corrections of the devices.

    Distribution

    The monitors were shipped to consignees located nationwide in the United States and to foreign consignees located worldwide.

    Quantity

    875 units