# FDA recall Z-2409-2024

> **Medtronic Xomed, Inc.** · Class I · device recall initiated 2024-06-24.

## 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

## Distribution

Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic Of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.

## Key facts

- **Recall number:** Z-2409-2024
- **Recalling firm:** Medtronic Xomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-24
- **Report date:** 2024-07-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jacksonville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2409-2024

## Citation

> AI Analytics. FDA recall Z-2409-2024. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-2409-2024. Source: US FDA. Licensed CC0.

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