fda_recall · device_recall · critical
Fresenius Kabi USA, LLC — Class I recall: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
- Event date
- 2026-06-10 00:00:00Z
- Observed
- 2026-07-09 22:52:22Z
- Source ID
- Z-2223-2026
- Payload hash
- 40a616f4ffde6c0acf02f1f8…
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. Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.