Fresenius Kabi USA, LLC: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 32 systems Lot/code info: Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2

UPC codes

00811505030122

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.