Fresenius Kabi recalls Ivenix Infusion System software version 5.2.1/5.2.2 due to potential incorrect alarms that may delay therapy or cause over-infusion. Affected units were corrected in software version 5.8.0 by May-August 2023.
Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
Fresenius Kabi is recalling the Ivenix Infusion System software versions 5.2.1 and 5.2.2 because they may cause incorrect alarms that delay therapy or lead to over-infusion. These issues were fixed in software version 5.8.0 by May through August 2023.
The software may trigger a 'Fail-Stop' alarm when loading an administration set during power-up, potentially delaying therapy. It may also fail to alert clinicians when a bolus dose exceeds safety limits, risking over-infusion of medication.
Patients using the Ivenix Infusion System with software versions 5.2.1 or 5.2.2 are affected. Healthcare providers administering treatments with these software versions are most at risk.
Check for software versions 5.2.1 or 5.2.2 on your Ivenix Infusion System. The recall covers units sold with the UDI-DI 00811505030122.
Verify your Ivenix Infusion System software version by checking the device settings or documentation.
Install software version 5.8.0 to resolve the issues, which was available from May through August 2023.
The software versions 5.2.1 and 5.2.2 had defects that could cause incorrect alarms or over-infusion of medication. These were fixed in version 5.8.0.
Check for software versions 5.2.1 or 5.2.2 on your Ivenix Infusion System. The recall covers units with UDI-DI 00811505030122.
The recall addresses potential delays in therapy or over-infusion, but the official notice does not specify a risk of serious injury.
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall Z-1283-2024 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall Z-1283-2024 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.
