BEUDAMED
    FDA Enforcement Class III Terminated

    3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.

    Recall: Z-2108-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2108-2021
    Event ID
    88209
    Classification
    Class III
    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 28, 2021
    Initiation Date
    May 27, 2021
    Classification Date
    July 21, 2021
    Termination Date
    August 11, 2022
    Address
    800 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2001, United States

    Description

    3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.

    Reason

    Telepack may not power on when using the 3AA battery cradle.

    Code Info

    Part Number 045-001699-01; Awaiting additional details

    Distribution

    Distributed US nationwide and Canada.

    Quantity

    804