# FDA recall Z-1623-2025

> **Medtronic Xomed, Inc.** · Class II · device recall initiated 2025-03-10.

## 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.

## Distribution

Worldwide - US Nationwide distribution including in the states of MD, MN, PA, OK, OH, FL, CO, GA, NC, KS, IL, WY, AK, NE, VA, MI, CA, NY, WI, UT, AZ, AR, TX, WA, AL, NJ, SD, MS, KY, TN, MO, OR, MT, MA, CT, NM, LA, WV, NH, DC, DE, IN, NV, IA, SC, ID, ME, HI, RI, VT, ND, GU, PR 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, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Namibia, Nepal, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapor

## Key facts

- **Recall number:** Z-1623-2025
- **Recalling firm:** Medtronic Xomed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-10
- **Report date:** 2025-04-30

- **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-1623-2025

## Citation

> AI Analytics. FDA recall Z-1623-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1623-2025. Source: US FDA. Licensed CC0.

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