FDA Medical Device Recalls (openFDA)
Fresenius Kabi USA, LLC: LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
- Recall number
- Z-1484-2024
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
- Status
- Open, Classified
- Initiated
- 2024-03-07
- Posted
- 2024-04-11
- Terminated
- not on file
- Reason
- Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
- Root cause
- Software Design Change
- Action
- 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).
- Quantity
- 17 units
- Distribution
- US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
- Lot, serial or model codes
- Product LVP-SW-0004; UDI-DI 00811505030122.
- 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