BEUDAMED
    FDA Enforcement Class II Ongoing

    5008X CAREsystem +CLiC +CDX;

    Recall: Z-0936-2026 · Reported December 24, 2025

    Enforcement

    Recall Number
    Z-0936-2026
    Event ID
    97934
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 24, 2025
    Initiation Date
    October 25, 2025
    Classification Date
    December 17, 2025
    Address
    920 Winter St Bld 920, Waltham, MA, 02451-1521, United States

    Description

    5008X CAREsystem +CLiC +CDX;

    Reason

    Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

    Code Info

    Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;

    Distribution

    Domestic: LA, MA, MN;

    Quantity

    115 units