BEUDAMED
    FDA Recall Terminated

    Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.

    Recall: Z-2380-2012 · Initiated June 6, 2012

    Recall

    Recall Number
    Z-2380-2012
    Event Number
    62939
    Firm
    Zoe Medical Incorporated
    FEI Number
    3003294644
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 6, 2012
    Posted
    September 14, 2012
    Terminated
    September 18, 2012
    Address
    460 Boston St, Topsfield, MA, 01983-1223

    Description

    Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.

    Reason

    Unit fails to power up, resulting in an equipment alarm

    Action

    The firm, Zoe Medical, coordinated with the Distributor via email on June 7, 2012. The email described the product, problem and actions to be taken. Zoe will remove product the site and return the units for correction. If you have any questions, contact Manager, Global Technical Support at 425-657-7200 ext 5508.

    Distribution

    Nationwide distribution: WA only.

    Quantity

    35 units