FDAHealthMay 6, 2026

Fresenius Kabi USA, LLC — LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

⚠️ 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.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: May 6, 2026

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.

What's affected?

Product: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Brand: Fresenius Kabi USA, LLC
Lot code: Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2

Additional details

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

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 32 systems.

View original FDA notice →

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