Device product
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Z-1048-2026
Product summary
- Event
- Event 98106
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30 units
- Official record key
device-enforcement:Z-1048-2026
Official wording
Reason: Emphasizing instructions for LVP duration programming located in the IFU.
Code information: Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
Distribution pattern: US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.
Derived failure modes
-
Unknown
Emphasizing instructions for LVP duration programming located in the IFU.