Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
FDA Recall Z-3153-2024 · Posted 2024-09-26
Recalling FirmFresenius Kabi USA, LLC
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2024-08-30
Product Quantity17 units
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.
Firm Action
An URGENT Medical Device Field Correction Important Safety Update notification letter dated 8/30/24 was sent to customers.
Required Actions for Users:
1. Please fill out the Customer Reply Form attached to this letter to acknowledge receipt.
2. If your facility further distributes or transfers products to satellite sites or other locations, please ask these locations to contact the email address on the Customer Reply Form so we can send notice to those satellites directly.
3. Install new software version (5.9.2) for the Ivenix Large Volume Pump (LVP). See details
below.
How To Obtain and Install Software Version 5.9.2
To request installation, please reach out promptly to your Fresenius Kabi representative (1-855- 354-6387 or [email protected]). They will push the new software update to your pumps. When the LVP version 5.9.2 software update has been sent to the LVP, the following prompt appears before the LVP is shut down.
Customer support - email
Ivenix_su [email protected]
Customer support - phone
1-855-354-6387 Normal business Hours are Monday through Friday 8:30 AM to 5 PM Eastern Time, After Hours Supported with Voicemail Messaging
Root Cause
Software design
Distribution Pattern
US Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.