LVP software of the Ivenix Infusion System recall: Software Issue
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Why was LVP software of the Ivenix Infusion System recalled?
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
- Product
- LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 32 systems
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- Recall date
- June 10, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)