BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0742-2013 · Initiated September 5, 2012

    Recall

    Recall Number
    Z-0742-2013
    Event Number
    63800
    Firm
    Mindray DS USA, Inc. d.b.a. Mindray North America
    FEI Number
    2221819
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 5, 2012
    Posted
    January 27, 2013
    Terminated
    October 22, 2013
    Address
    800 MacArthur Blvd., Mahwah, NJ, 07430

    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.

    Action

    Mindray DS USA Inc. sent an Urgent Product Corrective Action letter on September 5, 2012 via Fed Ex with delivery confirmation to all users. The letter identifies the affected product, problem and actions to be taken. Customers were instructed to contact their Mindray Service Representative at 1-800-288-2121 Monday through Friday 8:30-5:30 pm, to schedule a software upgrade.

    Distribution

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

    Quantity

    13 units