Fresenius Kabi recalls Ivenix Infusion System software version 5.2.0 due to potential screen freezing that can interrupt medication flow. Affected users should contact the company for updates.
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
Fresenius Kabi is recalling a specific software version for their Ivenix Infusion System. This software issue can cause the display to freeze, stopping medication flow and requiring immediate clinician intervention.
The software may freeze the display screen, causing it to become unresponsive. This leads to temporary stops in medication flow, which requires immediate action from the clinician to prevent patient harm.
Healthcare professionals using the Ivenix Infusion System with the affected software version are most at risk. Patients receiving medication through this system could experience interruptions in treatment.
Check for the Ivenix Infusion System software version 5.2.0 (LVP-SW-0004) on your device. The recall applies to units sold with this specific software version.
Verify your Ivenix Infusion System software version by checking the device's display or documentation.
Reach out to Fresenius Kabi for guidance on next steps if you have the affected software version.
The affected software version is Ivenix Infusion System (IIS) LVP Software version 5.2.0 (LVP-SW-0004).
The issue can cause temporary stops in medication flow, requiring immediate intervention by the clinician to prevent patient harm.
The recall record does not specify a fix; users should contact Fresenius Kabi for guidance.
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall Z-0002-2023 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall Z-0002-2023 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.
