Device product
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Z-2223-2026
Product summary
- Event
- Event 98929
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 32 systems
- Official record key
device-enforcement:Z-2223-2026
Official wording
Reason: Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
Code information: Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
Distribution pattern: US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Derived failure modes
-
Device software or design
software anomaly