BEUDAMED
    FDA Recall Terminated

    TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00

    Recall: Z-0554-2018 · Initiated July 14, 2017

    Recall

    Recall Number
    Z-0554-2018
    Event Number
    79005
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    FEI Number
    2221819
    Product Code
    MSX
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 14, 2017
    Terminated
    December 17, 2018
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430-2001

    Description

    TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00

    Reason

    A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate.

    Action

    Certified letters were sent to all affected customers on 07/14/2017, to offer a replacement of the battery charger.

    Distribution

    Distributed in 26 states: AL, CA, CO, FL, GA, IA, IN, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, SD, TX, UT, WA, and WY; and Puerto Rico.

    Quantity

    203