FDA Device recall Z-0002-2023
Ivenix Infusion System (IIS), LVP Software
- FDA Device
- Class I
- terminated
- Published 2022-10-12
On 2022-10-12 the FDA classified a Class I recall of Ivenix Infusion System (IIS), LVP Software by Fresenius Kabi Usa, citing the display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. How….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0002-2023 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-09-08 |
| Published | 2022-10-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | NJ, WI |
Product
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Reason
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
Identifiers
| code_info | UDI-DI: 00811505030122 version 5.2.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0002-2023%22
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