LVP software of the Ivenix Infusion System — Class II medical device recall Z-1282-2024
Completed recall by Fresenius Kabi USA, LLC, reported 2024-03-20, distributed nationwide. Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when a
| Recall number | Z-1282-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, North Andover, MA, United States |
| Recall initiated | 2022-09-16 |
| Classified | 2024-03-11 |
| Reported by FDA | 2024-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Reason classes | device malfunction, software |
| UPC / GTIN / UDI-DI | 00811505030122 |
Product
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1282-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.