FDA Medical Device Recalls (openFDA)
Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
- Recall number
- Z-3153-2024
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
- Status
- Open, Classified
- Initiated
- 2024-08-30
- Posted
- 2024-09-26
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software design
- 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 Ivenix_support@fresenius-kabi.com). 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 pport@fresenius-kabi.com 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
- Quantity
- 17 units
- Distribution
- US Nationwide.
- Lot, serial or model codes
- UDI-DI: 00811505030122; Software Version 5.9.1 and prior
- 510(k) numbers
- ["K183311"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3014732157
- Firm city
- North Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28