BEUDAMED
    FDA Enforcement Class II Terminated

    Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.

    Recall: Z-0742-2013 · Reported February 6, 2013

    Enforcement

    Recall Number
    Z-0742-2013
    Event ID
    63800
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. d.b.a. Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 6, 2013
    Initiation Date
    September 5, 2012
    Classification Date
    January 27, 2013
    Termination Date
    October 22, 2013
    Address
    800 MacArthur Blvd., Mahwah, NJ, 07430, United States

    Description

    Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.

    Reason

    Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.

    Code Info

    p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 OCOOO569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373

    Distribution

    US Nationwide Distribution including the states of: VA, TN, FL, & TX

    Quantity

    13 units