BEUDAMED
    FDA Recall Terminated

    Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT SpO2 measurement option

    Recall: Z-0611-03 · Initiated September 16, 2002

    Recall

    Recall Number
    Z-0611-03
    Event Number
    25501
    Firm
    Datex-Ohmeda
    FEI Number
    2183066
    Product Code
    DPZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 16, 2002
    Posted
    March 5, 2003
    Terminated
    July 2, 2004
    Address
    3030 Ohmeda Dr. Box 7550, Madison, WI, 53707

    Description

    Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT SpO2 measurement option

    Reason

    Falsely high blood oxygen saturation readings in some circumstances which could result in no alarm in a critical life-threatening situation.

    Action

    'Medical Device Advisory Notice' letters dated September 16, 2002 were sent to the consignees, gave recommendations about alternative monitoring for certain patients, and stated that there would be a field correction to reduce the possibility of the problem.

    Distribution

    Nationwide in the United States and worldwide.

    Quantity

    85