Official recall notice

FDA DeviceClass INotable

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

Recall date
2026-06-10
FDA class
Class I

Why it was recalled

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.

Recommended action

What to do

32 systems

Product description

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.

Verify with the official notice →
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