LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Published March 20, 2024 · Recall initiated: September 16, 2022
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- US Nationwide distribution in the states of WI and NJ.
- Lot
- UDI-DI 00811505030122 Software versions 5.0.1 and earlier.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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