BEUDAMED
    FDA Enforcement Class II 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 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2380-2012
    Event ID
    62939
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zoe Medical Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2012
    Initiation Date
    June 6, 2012
    Classification Date
    September 14, 2012
    Termination Date
    September 18, 2012
    Address
    460 Boston St, Topsfield, MA, 01983-1223, United States

    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

    Code Info

    Serial Numbers: FFD3291, FFD3292, FFD3293, FFD3294, FFD3295, FFD3296, FFD3297, FFD3298, FFD3299, FFD3300, FFD3301, FFD3302, FFD3303, FFD3304, FFD3306, FFD3307, FFD3308, FFD3309, FFD3310, FFD3312, FFD3313, FFD3314, FFD3315, FFD3316,FFD3317, FFD3318, FFD3319, FFD3320, FFD3321, FFD3579, FFD3771, FFD3772, FFD3814, FFD3815, FFD3817

    Distribution

    Nationwide distribution: WA only.

    Quantity

    35 units