FDA-Device2024-04-17Class I
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Fresenius Kabi USA, LLC
Hazard
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Sold states
US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
Affected count
17 units
Manufactured in
50 High St Ste 50, N/A, North Andover, MA, United States
Products
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1484-2024Don't want to check this manually?
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