FDA-Device2025-12-24Class I
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Fresenius Kabi USA, LLC
Hazard
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Sold states
US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
Affected count
30 units
Manufactured in
50 High St Ste 50, North Andover, MA, United States
Products
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0885-2026Don't want to check this manually?
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