Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Reported: October 12, 2022 Initiated: September 8, 2022 #Z-0002-2023
Product Description
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Reason for Recall
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.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 4 instances
- Distribution
- Domestic distribution to NJ and WI.
- Location
- North Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0. Recalled by Fresenius Kabi USA, LLC. Units affected: 4 instances.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 12, 2022. Severity: Critical. Recall number: Z-0002-2023.
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