NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4 — Class II medical device recall Z-1623-2025
Ongoing recall by Medtronic Xomed, Inc., reported 2025-04-30, distributed nationwide. Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which ma
| Recall number | Z-1623-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Xomed, Inc., Jacksonville, FL, United States |
| Recall initiated | 2025-03-10 |
| Classified | 2025-04-18 |
| Reported by FDA | 2025-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, IE, IL, IN, IS, IT, JO, JP, KR, KW, KY, LB, LK, LT, LU, LV, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PL, PT, QA, RO, RS, SA, SE, SG, SK, SV, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 9,788 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000002978, 00763000002985, 00763000002992, 00763000003005, 00763000395896, 00763000395902, 00763000401597, 00763000401603, 00763000528577, 00763000528584, 00763000709341, 00763000869823, 00763000945398, 00763000974312 |
| Model numbers | NIM4CM01, NIM4CM01RF, NIM4CPB1, NIM4CPB1RF, NIM4SWU143, NIM4SWU154, NIM4SWU164 |
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 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154; SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1623-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.