LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Pending LLM rewrite. Source: FDA_DEVICE Z-2223-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
Distribution
Distributed nationwide across the United States.
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