Medical Device Recall: LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Fresenius Kabi USA, LLC · September 16, 2022
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of WI and NJ.
States Affected
NATIONWIDE
Quantity Affected
3
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1282-2024
Status: completed
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