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Recall Observatory FDA recall evidence

Device product

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

Z-2223-2026

May 06, 2026

Class I

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 98929
Status
Ongoing
Classification
Class I
Quantity
32 systems
Official record key
device-enforcement:Z-2223-2026

Official wording

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

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software anomaly