FDA Device recall Z-1282-2024
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
- FDA Device
- Class II
- completed
- Published 2024-03-20
On 2024-03-20 the FDA classified a Class II recall of LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 by Fresenius Kabi Usa, citing 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, re….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1282-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-09-16 |
| Published | 2024-03-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
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.
Identifiers
| code_info | UDI-DI 00811505030122 Software versions 5.0.1 and earlier. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
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FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
All Fresenius Kabi Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1282-2024%22
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