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Recall Observatory FDA recall evidence

Device product

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

Z-0002-2023

September 08, 2022

Class I

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 90845
Status
Terminated
Classification
Class I
Quantity
4 instances
Official record key
device-enforcement:Z-0002-2023

Official wording

Reason: 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.

Code information: UDI-DI: 00811505030122 version 5.2.0

Distribution pattern: Domestic distribution to NJ and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.