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