BEUDAMED
    FDA Enforcement Class I Ongoing

    LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

    Recall: Z-2223-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2223-2026
    Event ID
    98929
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Kabi USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2026
    Initiation Date
    May 6, 2026
    Classification Date
    June 3, 2026
    Address
    50 High St Ste 50, North Andover, MA, 01845-2620, United States

    Description

    LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

    Reason

    Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.

    Code Info

    Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2

    Distribution

    US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.

    Quantity

    32 systems