LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Fresenius Kabi USA, LLC
The 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. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
UPC 00811505030122Would you have heard about this one?
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