Fresenius Kabi Ivenix Infusion System software recalled for frozen display screen
Stop using Ivenix Infusion System version 5.2.0
The display screen on the Ivenix Infusion System (version 5.2.0) can freeze and become unresponsive, causing medication or fluid delivery to stop temporarily. While an alarm sounds and lights flash, the frozen screen may not clearly show the alarm condition, requiring a clinician to intervene immediately.
- If you operate this device, contact Fresenius Kabi USA, LLC immediately for instructions
- Do not rely on the display screen alone to confirm alarm conditions
- Monitor the device closely for any signs of freezing or unresponsiveness
- Report any instances of screen freezing to Fresenius Kabi and the FDA
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2023More Fresenius Kabi USA, LLC recalls
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