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.
- Hazard
- software-anomaly
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.
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