Fresenius Kabi recalls Ivenix Infusion System software version 5.10.2 due to potential false battery alarms that may shut down the pump. Affected units have specific product codes and software versions.
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.
Fresenius Kabi is recalling the Ivenix Infusion System software version 5.10.2 because it can falsely report low battery and shut down the pump without reconnection to power. This could interrupt critical medical treatment if the pump stops unexpectedly.
The software anomaly causes the pump to report a false battery health value of 69%, triggering a battery depletion alarm that shuts down the pump. This requires reconnection to AC power to restart, which could interrupt medical treatment if not handled promptly.
Patients using the Ivenix Infusion System with the affected software version are most at risk. Healthcare providers managing these patients may need to take action to prevent treatment interruptions.
Check for product code LVP-SW-0005 and software version 5.10.2 on the Ivenix Infusion System. The UDI-DI number 00811505030122 also identifies affected units.
Verify the software version on your Ivenix Infusion System; affected units have version 5.10.2.
Reach out to Fresenius Kabi for guidance on next steps if you have the affected software version.
The software anomaly can cause the pump to report a false battery health value of 69%, triggering a battery depletion alarm that shuts down the pump without reconnection to AC power.
Check for product code LVP-SW-0005 and software version 5.10.2 on the system, or UDI-DI number 00811505030122.
Reconnect the pump to AC power to restart it, but contact Fresenius Kabi for specific guidance if you have the affected software version.
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall Z-2223-2026 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall Z-2223-2026 from Fresenius Kabi. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
