BEUDAMED
    FDA Enforcement Class II Ongoing

    Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385

    Recall: Z-0217-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0217-2025
    Event ID
    95409
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2024
    Initiation Date
    September 19, 2024
    Classification Date
    October 24, 2024
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385

    Reason

    The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.

    Code Info

    UDI/DI 00887761968653, All Serial Numbers

    Distribution

    Worldwide distribution.

    Quantity

    542 units