Device product
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Z-0378-2026
Product summary
- Event
- Event 97554
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-0378-2026
Official wording
Reason: Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Code information: Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
Distribution pattern: US Nationwide distribution in the state of Minnesota.
Derived failure modes
-
Unknown
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.