LVP software of the Ivenix Infusion System — Class II medical device recall Z-1283-2024
Completed recall by Fresenius Kabi USA, LLC, reported 2024-03-20, distributed nationwide. Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm wh
| Recall number | Z-1283-2024 |
|---|---|
| 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 | 2023-05-10 |
| Classified | 2024-03-11 |
| Reported by FDA | 2024-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 6 us |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00811505030122 |
Product
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Reason for recall
Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
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-1283-2024. 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.