BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0554-2018 · Reported February 14, 2018

    Enforcement

    Recall Number
    Z-0554-2018
    Event ID
    79005
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 14, 2018
    Initiation Date
    July 14, 2017
    Classification Date
    February 8, 2018
    Termination Date
    December 17, 2018
    Address
    800 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2001, United States

    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.

    Code Info

    All battery chargers with part number 115-030108-00

    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