BEUDAMED
    FDA Enforcement Class I Ongoing

    Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.

    Recall: Z-3153-2024 · Reported October 2, 2024

    Enforcement

    Recall Number
    Z-3153-2024
    Event ID
    95240
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Kabi USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2024
    Initiation Date
    August 30, 2024
    Classification Date
    September 26, 2024
    Address
    50 High St Ste 50, North Andover, MA, 01845-2620, United States

    Description

    Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.

    Reason

    The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.

    Code Info

    UDI-DI: 00811505030122; Software Version 5.9.1 and prior

    Distribution

    US Nationwide.

    Quantity

    17 units