FDA-Device2022-10-12Class I
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Fresenius Kabi USA, LLC
Hazard
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
Sold states
Domestic distribution to NJ and WI.
Affected count
4 instances
Manufactured in
50 High St Ste 50, N/A, North Andover, MA, United States
Products
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief