BEUDAMED
    FDA Recall Terminated

    Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.

    Recall: Z-2810-2020 · Initiated June 18, 2020

    Recall

    Recall Number
    Z-2810-2020
    Event Number
    86025
    Firm
    Philips North America, LLC
    FEI Number
    1218950
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 18, 2020
    Terminated
    January 10, 2023
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.

    Reason

    A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger.

    Action

    Philips Healthcare sent a customer notification letter dated June 2020 explaining the potential issues observed with their products. This letter instructs the consumer to contact the company with any reports of issues associated with this failure.

    Distribution

    World wide distribution. Firm reports distributing more product then quantity manufactured. Clarification requested. And received. Firm made error in counting number of batteries distributed.

    Quantity

    24,545 Units