CLASS II ONGOING Device recall · Reported 8 Jun 2022 · FDA Enforcement Report

NIM Vital Console 4.0 recalled by Medtronic Xomed

Medtronic Xomed is recalling NIM Vital Console 4.0 (, distributed nationwide in the US. The recall was initiated on 3 May 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled18 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1223-2022
FDA event ID: 90163
Recalling firm: Medtronic Xomed, Jacksonville, FL
Classification: Class II
Status: Ongoing
Recall initiated: 3 May 2022
FDA classified: 2 Jun 2022
Reported: 8 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

3 May 2022	Recall initiated by company
2 Jun 2022	Classified by FDA	+30 days
8 Jun 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Software anomaly was identified.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.

Nationwide Colorado New Jersey Texas

Questions about this recall

Why was it recalled?

Software anomaly was identified.

Which lots are affected?

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.

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 90163

This product is part of a recall event; the main page for the event is NIM Vital Patient Interface 4.0 recalled by Medtronic Xomed.

Reported	Class	Recall	Company	Reason	Where
8 Jun 2022	CLASS II	NIM Vital Patient Interface 4.0 recalled by Medtronic Xomed	Medtronic Xomed	Device Malfunction	Nationwide

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