BEUDAMED
    FDA Enforcement Class II Ongoing

    Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085

    Recall: Z-1417-2025 · Reported April 2, 2025

    Enforcement

    Recall Number
    Z-1417-2025
    Event ID
    96286
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 2, 2025
    Initiation Date
    February 25, 2025
    Classification Date
    March 21, 2025
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085

    Reason

    There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

    Code Info

    UID/DI 00887761974081, All serial numbers manufactured until 11/14/2024.

    Distribution

    US Nationwide distribution.

    Quantity

    10 units