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

Medical DevicesSource: FDA (device) · Date: 2026-06-10

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Fresenius Kabi USA, LLC
Product
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Reason / hazard
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.
Classification
Class I
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-05-06
Code info
Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
Product quantity
32 systems
Voluntary mandated
Voluntary: Firm initiated
City
North Andover
State
MA
Country
United States
Event id
98929
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