Moderate FDA (Devices)·Z-1223-2022·Announced 2022-06-08

Medtronic NIM Vital Console 4.0 Surgical Nerve Monitoring Device Software Anomaly Recall

Medtronic Xomed is recalling 18 units of the NIM Vital Console 4.0 surgical nerve monitoring device due to an identified software anomaly. Distribution was confirmed in Texas, Colorado, New Jersey, and France.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II classification with no reported illnesses or injuries. The hazard is identified as a software anomaly with no articulated patient risk, making this a precautionary recall warranting Moderate severity.

Plain-English summary

Medtronic Xomed, Inc. is recalling 18 units of the NIM Vital Console 4.0 (Model Number NIM4CM01) with Software version 1.3.2, a surgical nerve monitoring device used during operative procedures.

A software anomaly was identified in the device. No reported illnesses or injuries associated with this anomaly have been disclosed.

The affected devices were distributed worldwide, with confirmed US distribution in Texas, Colorado, and New Jersey, as well as in France. Multiple lot numbers are affected by this recall.

The recalled product

Product: NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Manufacturer: Medtronic Xomed, Inc.
Category: Medical Device — Surgical Monitoring Equipment
Hazard: software-anomaly
Affected units: 18

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Medtronic Xomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Medtronic Xomed, Inc.

See all →

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Severe
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Same hazard · software anomaly