[pending] NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF N
Pending LLM rewrite. Source: FDA_DEVICE Z-1623-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
The recalled product
- Product
- NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRA
- Manufacturer
- Medtronic Xomed, Inc.
- Category
- Medical Device — Devices
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 (13)
- 00763000395896
- 00763000401597
- 00763000528577
- NIM4CM01RF/00763000002992
- NIM4CPB1/763000002985
- 00763000401603
- 00763000395902
- 00763000528584
- NIM4CPB1RF/00763000003005
- NIM4SWU143/00763000709341
- 00763000869823
- NIM4SWU154/00763000945398
- NIM4SWU164/00763000974312
Distribution
Distributed nationwide across the United States.
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