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

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 execu…

Recall #: Z-1283-2024
Affected scope: 6 US
Initiated: May 10, 2023

Compiled from official public sources by the publisher. · Updated September 2026

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Fresenius Kabi USA, LLC recalled LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 - a moderate-severity action.

LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 was recalled by Fresenius Kabi USA, LLC in March 20, 2024. Reason: Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm w…. Check the official notice for the remedy. Verify recall #Z-1283-2024 with the FDA Devices before acting.

The recall

Fresenius Kabi USA, LLC issued this moderate-severity FDA Devices recall-Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm w….

Moderate
severity level: Class II
classification: March 20, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1283-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Completed
Recall number	Z-1283-2024
Date reported	March 20, 2024
Date initiated	May 10, 2023
Recalling firm	Fresenius Kabi USA, LLC
Firm location	North Andover, MA
Affected scope	6 US
Distribution	US Nationwide distribution to the states of CA, CO, NJ, WI, UT.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1283-2024) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004. Recalled by Fresenius Kabi USA, LLC. Units affected: 6 US.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 20, 2024. Severity: Moderate. Recall number: Z-1283-2024.

Where was the recalled product distributed? ▼

Distribution: US Nationwide distribution to the states of CA, CO, NJ, WI, UT..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

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This recall: FDA Devices, reported March 20, 2024. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026