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MEDICAL DEVICE RECALLCRITICAL

Ivenix Infusion System LVP Software

Fresenius Kabi is recalling Ivenix Infusion System LVP software due to a potential battery-health reporting error that may cause pump shutdown.

What to do

Ensure the infusion pump is connected to AC mains power whenever possible. Monitor the device for battery-depletion alarms and contact your clinical engineering department or Fresenius Kabi for software update instructions.

Posted
Updated
Agency
Firm
Fresenius Kabi USA, LLC
Recall ID
98929
Status
ONGOING

Why it was recalled

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.

How to identify it

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

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Editorial summary by Recall Canary · last updated 2026-06-04 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification