Z-1283-2024Class II

LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

Name: Z-1283-2024 LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Creator: Fresenius Kabi USA, LLC
Published: 2023-05-10
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2023-05-10 / Completed / root cause: software

FDA source

Fresenius Kabi USA, LLC began a recall of LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 on 2023-05-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-1283-2024
Classification: Class II
Status: Completed
Initiated: 2023-05-10
Posted: 2024-03-11
Recalling firm: Fresenius Kabi USA, LLC
Product: LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Product code: FRN Pump, Infusion
Reason for recall: 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 tag: software
FDA 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 in commerce: 6 US
Distribution: US Nationwide distribution to the states of CA, CO, NJ, WI, UT.
Product codes and lots: UDI-DI 00811505030122 Software versions 5.2.1/5.2.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1283-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1283-2024	Class II	Completed	Voluntary: Firm initiated	2024-03-20	2024-03-11

Product code FRN

K183311Class IIIvenix Infusion System (IIS)Ivenix, Inc. / cleared 2019-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)