Z-0885-2026 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2025
- Initiation Date
- November 14, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
Product Description
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Reason for Recall
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Distribution Pattern
US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
Code Information
Software Versions 5.10.1 and prior; UDI: 00811505030122.