[pending] Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Pending LLM rewrite. Source: FDA_DEVICE Z-0002-2023.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00811505030122 version 5.2.0
Distribution
Distributed in 2 states:
- NJ
- WI
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