FDA Medical Device Recalls (openFDA)
Fresenius Kabi USA, LLC: LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
- Recall number
- Z-1282-2024
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
- Status
- Completed
- Initiated
- 2022-09-16
- Posted
- 2024-03-11
- Terminated
- not on file
- Reason
- Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.
- Root cause
- Software design
- Action
- The issue was resolved through an update of the software to Version 5.2.1, which was installed at customer sites in September 2022. The firm did not issue a customer letter at the time. According to the firm, this issue has been resolved in all fielded product. There have been two subsequent software upgrades since Version 5.2.1 was released. Consignees are now on v 5.8.0.
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of WI and NJ.
- Lot, serial or model codes
- UDI-DI 00811505030122 Software versions 5.0.1 and earlier.
- 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