FDA Medical Device Recalls (openFDA)
Fresenius Kabi USA, LLC: LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
- Recall number
- Z-1283-2024
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
- Status
- Completed
- Initiated
- 2023-05-10
- Posted
- 2024-03-11
- Terminated
- not on file
- Reason
- Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
- Root cause
- Software design
- Action
- Both issues were resolved through an update of the software to Version 5.8.0, which was installed at customer sites between May and August 2023. The firm did not issue a customer letter at the time. According to the firm, this issue has been resolved in all fielded product.
- Quantity
- 6 US
- Distribution
- US Nationwide distribution to the states of CA, CO, NJ, WI, UT.
- Lot, serial or model codes
- UDI-DI 00811505030122 Software versions 5.2.1/5.2.2
- 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
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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