FDA-Device2024-10-02Class I
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Fresenius Kabi USA, LLC
Hazard
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.
Sold states
US Nationwide.
Affected count
17 units
Manufactured in
50 High St Ste 50, North Andover, MA, United States
Products
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3153-2024Don't want to check this manually?
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