BEUDAMED
    FDA Enforcement Class II Ongoing

    Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386

    Recall: Z-0218-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0218-2025
    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) V, Product code REF 2065386

    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 00887761973794, All Serial Numbers

    Distribution

    Worldwide distribution.

    Quantity

    13 units