BEUDAMED
    FDA Recall Terminated

    TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China

    Recall: Z-0321-2017 · Initiated September 8, 2016

    Recall

    Recall Number
    Z-0321-2017
    Event Number
    75062
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    FEI Number
    2221819
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 8, 2016
    Terminated
    May 4, 2017
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430-2001

    Description

    TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China

    Reason

    Mindray has become aware that the TD60 Display Telemetry Transmitter used with the BeneVision Central Station may crack on the bezel surrounding the display and also the transmitter may not power on or will power on but display an error message.

    Action

    Mindray sent a "Medical Device Action" letter dated September 8, 2016 via UPS to their affected customers.

    Distribution

    US and Canada

    Quantity

    1,278 units