FDA Device recall Z-3153-2024
Ivenix Infusion System (IIS), LVP Software
- FDA Device
- Class I
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class I recall of Ivenix Infusion System (IIS), LVP Software by Fresenius Kabi Usa, citing the software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3153-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-08-30 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Reason
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
Identifiers
| code_info | UDI-DI: 00811505030122; Software Version 5.9.1 and prior |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3153-2024%22
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