Z-0002-2023Class I

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

Name: Z-0002-2023 Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Creator: Fresenius Kabi USA, LLC
Published: 2022-09-08
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2022-09-08 / Terminated / root cause: software

FDA source

Fresenius Kabi USA, LLC began a recall of Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 on 2022-09-08. FDA classified it as Class I and gives the reason as "The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0002-2023
Classification: Class I
Status: Terminated
Initiated: 2022-09-08
Posted: 2022-10-06
Terminated: 2024-09-10
Recalling firm: Fresenius Kabi USA, LLC
Product: Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Product code: PHC Infusion Safety Management Software
Reason for recall: The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
Root cause tag: software
FDA root cause: Software design
Action: On September 8, 2022, the company notified affected customers via phone call and emailed letter. Customers were instructed to do the following: 1. If a high priority Pump Problem alarm occurs, the LVP should be powered down by holding the power button for 10 seconds then releasing the power button so that the screen goes dark, then pressing the power button again to re-start the pump. Alternatively, if you have another LVP available, you may use it to resume infusion. 2. Inform potential users of the product within your organization of this notification. If your facility further distributes or transfers products amongst satellite sites or other locations, please disseminate this information accordingly. Fresenius Kabi has updated the software to rectify the condition. The updated software is currently available. Please schedule a service call at your earliest convenience to have it installed. Customer support: [email protected]; 1-978-775-8100
Quantity in commerce: 4 instances
Distribution: Domestic distribution to NJ and WI.
Product codes and lots: UDI-DI: 00811505030122 version 5.2.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0002-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0002-2023	Class I	Terminated	Voluntary: Firm initiated	2022-10-12	2022-10-06

Product code PHC

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)