Device product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Z-0885-2026
Product summary
- Event
- Event 98009
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 30 units
- Official record key
device-enforcement:Z-0885-2026
Official wording
Reason: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Code information: Software Versions 5.10.1 and prior; UDI: 00811505030122.
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.
Derived failure modes
-
Device software or design
Software version 5.10.1 and earlier contain anomalies