Unrated Medical device recall · FDA · Published May 3, 2022

Medtronic Xomed NIM Vital Patient Interface 4.0 Software Anomaly Recall

Medtronic Xomed recalls NIM Vital Patient Interface 4.0 with software version 1.3.2 due to a software anomaly. Affected units have specific model numbers and lot numbers listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1224-2022Medical device Medtronic Xomed ›

Recall notice

Software anomaly was identified.

Take action

Contact the company

Recalling firmMedtronic Xomed, Inc.6743 Southpoint Dr N · Jacksonville, FL 32216-6218

✎ GovInfoNow plain-language explainer

Medtronic Xomed is recalling NIM Vital Patient Interface 4.0 devices with software version 1.3.2 because of a software anomaly. This recall matters because the software issue could potentially cause problems with device operation, though the exact risk is not specified in the recall notice. Read more at govinfonow.com/recall/60734-medtronic-xomed-nim-vital-patient-interface-4-0-software-anomaly.

Source Summary by GovInfoNow · govinfonow.com/recall/60734-medtronic-xomed-nim-vital-patient-interface-4-0-software-anomaly · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1224-2022

Cite this page

“Medtronic Xomed NIM Vital Patient Interface 4.0 Software Anomaly Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60734-medtronic-xomed-nim-vital-patient-interface-4-0-software-anomaly. Based on FDA recall #Z-1224-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1224-2022%22&limit=1).

The FDA announced on May 3, 2022, that Medtronic Xomed, Inc. is recalling NIM Vital Patient Interface 4.0 units due to a software anomaly. The agency issued recall number Z-1224-2022 for the Class II voluntary recall.

How to tell if you have it

Brand: Medtronic Xomed
Product: NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) with Software version 1.3.2
Model Number: NIM4CPB1
UDI/DI: 00763000002985
Lot numbers: P1910256, P1910260, P1910402, P1910404, P2008073, P2008130, P2008131, 00763000395902, P2026275, P2026290, P2026329, P2026330, P2026357, P2026388, P2026389, P2026680, P2026681, P2026718, P2026719, P2026793, P2026956, P2026957, P2026958, P2026959, P2026981, P2026994, P2026995, P2127005, P2127006, P2127013
Units affected: 29

The hazard

A software anomaly was identified in the recalled devices, according to FDA records.

Context

GovInfoNow's records show Medtronic Xomed, Inc. has 11 other recalls on record since 2019-11-13. Other recent recalls of similar products include Medtronic Xomed IPC POWEREASE System Recall (2025-07-17), Medtronic Xomed NIM Vital Nerve Monitoring System Recall (2025-03-10), and Medtronic Ultra Round Steel Cutting Bur Recall (2024-07-05). Other recent recalls of similar products include Fresenius Medical Care 5008X CAREsystem Recall (2025-10-25), Philips Azurion 5 M12 System Software Recalls (2026-01-26), and Medtronic Restore CP App Model A71100 Software Issue (2025-11-20).

How to tell if you have this one

Check if your device has model number NIM4CPB1 and software version 1.3.2. Affected units include specific lot numbers listed in the recall notice.

Brand
Medtronic Xomed
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.

Recall number	Product, codes & lots	Quantity
Z-1223-2022	NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2; Model Number: NIM4CM01; UDI/DI: 00763000395896, lot numbers: C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223 and 00763000002978, lot numbers: C1915048, C1915078, C1915099, C1915188, C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223.	18 units
Z-1224-2022	NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2; Model Number: NIM4CPB1; UDI/DI: 00763000002985, lot numbers: P1910256, P1910260, P1910402, P1910404, P2008073, P2008130, P2008131 and 00763000395902, lot numbers: P2026275, P2026290, P2026329, P2026330, P2026357, P2026388, P2026389, P2026680, P2026681, P2026718, P2026719, P2026793, P2026956, P2026957, P2026958, P2026959, P2026981, P2026994, P2026995, P2127005, P2127006, P2127013	29 units

Based on the official FDA remedy

What to do — step by step

Check Device Details
Verify your device's model number and software version to see if it matches the recalled units.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 3 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Colorado, New Jersey, Texas.

Recall timeline

FDA published this recall 36 days after the firm started it.

May 3, 2022Firm started the recall
Jun 2, 2022FDA classified it Class II
Jun 8, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/60734-medtronic-xomed-nim-vital-patient-interface-4-0-software-anomaly">Medtronic Xomed NIM Vital Patient Interface 4.0 Software Anomaly Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1224-2022 (May 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1224-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.