11
Mar
2024

FDA Recall: Software Defect May Cause an Incorrect Fail-Stop Alarm

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Company: Fresenius Kabi USA, LLC
Date of Enforcement Report: 3/11/2024
Class II

PRODUCT

LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

Recall Number:

Z-1282-2024

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Fresenius Kabi USA, LLC

VOLUME OF PRODUCT IN COMMERCE:

3

DISTRIBUTION:

US Nationwide distribution in the states of WI and NJ.

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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