Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Sof
Recalled Product
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Hazard / Issue
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
Issued by
FDA
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