BEUDAMED
    FDA Enforcement Class II Terminated

    TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.

    Recall: Z-2634-2017 · Reported July 5, 2017

    Enforcement

    Recall Number
    Z-2634-2017
    Event ID
    77390
    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
    July 5, 2017
    Initiation Date
    April 28, 2017
    Classification Date
    June 27, 2017
    Termination Date
    March 22, 2019
    Address
    800 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2001, United States

    Description

    TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.

    Reason

    Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.

    Code Info

    two sales brochures: p/n: 0002-08-30034 and 0002-08-30035 two copies of labels: 047-014270-00, 047-010964-00, 047-018754-00 two copies of operator's manuals: 115-040812-00 and TNC 14-FZ007-F-001

    Distribution

    US Nationwide Distribution

    Quantity

    2718 batteries