Ivenix Infusion System (Fresenius Kabi) – Software Defect (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
UDI-DI 00811505030122 Software versions 5.2.1/5.2.2
Products Sold
UDI-DI 00811505030122 Software versions 5.2.1/5.2.2
Fresenius Kabi USA, LLC is recalling LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 due to Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or co. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
Recommended Action
Per FDA guidance
Both issues were resolved through an update of the software to Version 5.8.0, which was installed at customer sites between May and August 2023. The firm did not issue a customer letter at the time. According to the firm, this issue has been resolved in all fielded product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026