Fresenius Kabi recalls Ivenix Infusion System software versions 5.9.1 and older due to potential alarms, pump failure, or unresponsive screens during therapy, risking serious harm or death.
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
Fresenius Kabi is recalling older versions of the Ivenix Infusion System software (5.9.1 and prior) because flaws could cause alarms, pump malfunctions, or unresponsive screens while delivering therapy, potentially causing serious harm or death to patients.
The software anomalies can trigger alarms, cause the infusion pump to stop working, or make the screen unresponsive during therapy. This could lead to serious patient harm or death if the pump fails to deliver medication properly.
Patients using the Ivenix Infusion System with the recalled software versions are at risk. Healthcare providers and caregivers responsible for administering the therapy are most affected.
Check if your Ivenix Infusion System software version is 5.9.1 or older. The software version is listed in the device's settings or documentation.
Immediately stop using the infusion system if it has software version 5.9.1 or older, as it could cause serious harm or death.
Software versions 5.9.1 and older are affected.
Check the software version in your Ivenix Infusion System settings or documentation.
The recall record does not mention a fix or remedy.
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall Z-3153-2024 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall Z-3153-2024 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.
