Recall- Software Error Can Lead to Temporary Cessation of Medication Flow

Company: Fresenius Kabi USA, LLC
Date of Enforcement Report: 10/6/2022
Class I


Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

Recall Number:



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 USA, LLC


4 instances


Domestic distribution to NJ and WI.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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