BEUDAMED
    FDA Recall Terminated

    Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR), Respiration rate.

    Recall: Z-2549-2016 · Initiated June 23, 2016

    Recall

    Recall Number
    Z-2549-2016
    Event Number
    74704
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    FEI Number
    2221819
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 23, 2016
    Terminated
    March 28, 2017
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430-2001

    Description

    Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR), Respiration rate.

    Reason

    Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.

    Action

    Mindray DS USA inc sent a recall letter on 6/23/2016 to their customers.

    Distribution

    Nationwide, Canada

    Quantity

    360 units