Fresenius Kabi USA, LLC LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
Product LVP-SW-0004, UDI-DI 00811505030122.
Products Sold
Product LVP-SW-0004; UDI-DI 00811505030122.
Fresenius Kabi USA, LLC is recalling LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. due to Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Recommended Action
Per FDA guidance
A letter titled URGENT - Medical Device Field Correction, dated 3/7/24, was delivered by hand to consignees or by mail notifying them of this recall event. This notice details eleven software anomalies that could pose a potential risk of serious patient harm or death and the mitigations consignees should perform until software is updated. Consignees are to update their software to LVP software version 5.9.1 by reaching out to their Fresenius Kabi representative at 1-978-775-8100 to schedule installation. Consignees are to complete and return the Customer Reply Form via fax or email. Questions about the recall notice can be directed to Fresenius Kabi by email at Ivenix_support@fresenius-kabi.com or by phone at 1-978-775-8100 (Monday through Friday from 8:30 am to 5:00 pm).
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 noticeDistribution
As reported by FDA
CA, CO, ID, MI, NE, NV, NJ, OK, TX, UT, VA, WA, WI
Page updated: Jan 10, 2026