NIM Vital Nerve Monitoring systems — Class I medical device recall Z-2409-2024
Ongoing recall by Medtronic Xomed, Inc., reported 2024-07-31, distributed nationwide. Potential for false negative response on the NIM Vital Nerve Monitoring System
| Recall number | Z-2409-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Xomed, Inc., Jacksonville, FL, United States |
| Recall initiated | 2024-06-24 |
| Classified | 2024-07-24 |
| Reported by FDA | 2024-07-31 |
| 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, LT, LU, LV, MX, MY, NL, NO, NZ, OM, PA, PH, PL, PT, QA, RO, RS, SA, SE, SG, SK, SV, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 7,804 units |
| UPC / GTIN / UDI-DI | 00763000002978, 00763000002985, 00763000002992, 00763000003005, 00763000395896, 00763000395902, 00763000401597, 00763000401603, 00763000528577, 00763000528584, 00763000709341, 00763000869823 |
| Lot numbers | 0226074760, 0226076883, 0226086936, 0226096411, 10328, 1850079, 1850082, 1850083, 1850093, 1850095, 314102, C1915008, C1915009, C1915012, C1915013, C1915014, C1915015, C1915018, C1915020, C1915022, C1915025, C1915027, C1915028, C1915030, C1915031, C1915032, C1915038, C1915039, C1915040, C1915042, C1915048, C1915053, C1915057, C1915061, C1915062, C1915063, C1915064, C1915065, C1915066, C1915068 and 460 more |
| Model numbers | NIM4CM01, NIM4CM01RF, NIM4CPB1, NIM4CPB1RF, NIM4SWU143 |
Product
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143
Reason for recall
Potential for false negative response on the NIM Vital Nerve Monitoring System
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-2409-2024. 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.