LVP software of the Ivenix Infusion System recall: Software Issue
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Why was LVP software of the Ivenix Infusion System recalled?
Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
UDI-DI 00811505030122 Software versions 5.0.1 and earlier.
- Product
- LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of WI and NJ.
- Recall date
- March 20, 2024
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)