Fresenius Kabi recalls Ivenix Infusion System software versions 5.0.1 and earlier due to potential incorrect alarms causing therapy delays or harm. Affected users should check their software version.
Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.
Fresenius Kabi is recalling older software versions of the Ivenix Infusion System that may cause incorrect alarms when an upstream occlusion is present. This could delay therapy and potentially cause harm to patients.
The software defect can trigger a non-recoverable 'Fail-Stop' pump alarm when an upstream occlusion is present, causing therapy delays. This may result in no harm to serious harm depending on the situation.
Patients using the Ivenix Infusion System with software versions 5.0.1 or earlier are affected. Those with upstream occlusions during infusion may be at higher risk.
Check if your Ivenix Infusion System has software version 5.0.1 or earlier. The software version is part of the UDI-DI 00811505030122.
Look for the software version on your Ivenix Infusion System; versions 5.0.1 or earlier are affected.
The recall addresses a potential risk of incorrect alarms that could delay therapy and cause harm, but the software issue was resolved in version 5.2.1 installed in September 2022.
Check your software version; versions 5.0.1 or earlier are affected, as indicated by the UDI-DI 00811505030122.
The official recall does not specify a remedy, so you should check for software updates or contact Fresenius Kabi for assistance.
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall Z-1282-2024 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall Z-1282-2024 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.
