BEUDAMED
    FDA Enforcement Class II Terminated

    Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.

    Recall: Z-2737-2015 · Reported September 16, 2015

    Enforcement

    Recall Number
    Z-2737-2015
    Event ID
    71934
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 16, 2015
    Initiation Date
    July 27, 2015
    Classification Date
    September 4, 2015
    Termination Date
    May 2, 2017
    Address
    800 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2001, United States

    Description

    Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.

    Reason

    The DPM 7 Monitors may display a black screen.

    Code Info

    Lot #14A18, PN: 6800F-PA00001, Serial Numbers: DU- 46002583, DU-46002587, DU-46002588, DU-46002589, DU-46002592, DU-46002594, DU-46002595, DU-46002596, DU-46002599, DU-46002600, DU-46002601, DU-46002605 and DU-46002606

    Distribution

    Distributed to the states of CT, IA, KY, MS, PA, UT and WA.

    Quantity

    13 units