Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Reported: October 2, 2024 Initiated: August 30, 2024 #Z-3153-2024
Product Description
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Reason for Recall
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 17 units
- Distribution
- US Nationwide.
- Location
- North Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.. Recalled by Fresenius Kabi USA, LLC. Units affected: 17 units.
Why was this product recalled? ▼
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2024. Severity: Critical. Recall number: Z-3153-2024.
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