Fresenius Kabi recalls Ivenix Infusion System software version 5.8.0 due to potential underdose, overdose, or delayed therapy causing serious harm or death.
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Fresenius Kabi is recalling the Ivenix Infusion System software version 5.8.0 because software anomalies could cause underdose, overdose, or delayed therapy, risking serious patient harm or death.
The software has anomalies that could cause the system to deliver incorrect medication doses or delay therapy. This might result in underdose, overdose, or delayed treatment, which could lead to serious harm or death.
Patients using the Ivenix Infusion System with the affected software version are at risk. Healthcare providers who administer the system may also be affected.
Check if your Ivenix Infusion System software version is 5.8.0. The product code is LVP-SW-0004 with UDI-DI 00811505030122.
Immediately stop using the Ivenix Infusion System with the affected software version to prevent potential underdose, overdose, or delayed therapy.
The affected software version is 5.8.0 of the Ivenix Infusion System (IIS).
Check if your Ivenix Infusion System software version is 5.8.0. The product code is LVP-SW-0004 with UDI-DI 00811505030122.
Immediately stop using the system to prevent potential underdose, overdose, or delayed therapy.
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall Z-1484-2024 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall Z-1484-2024 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.
