BEUDAMED
    FDA Enforcement Class II 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 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2549-2016
    Event ID
    74704
    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
    August 24, 2016
    Initiation Date
    June 23, 2016
    Classification Date
    August 16, 2016
    Termination Date
    March 28, 2017
    Address
    800 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2001, United States

    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.

    Code Info

    100-00080-00 - Dyrline II Water Trap, Adult 115-020919-00- CO2 Module with Accessory Kit, Adult and Pediatric Lot #1534, 1537, 1538, 1541, 1545, 1547, 1548, 1602, and 1606

    Distribution

    Nationwide, Canada

    Quantity

    360 units