[pending] LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Pending LLM rewrite. Source: FDA_DEVICE Z-2223-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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