NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED,
Summary
The FDA issued a Class II for NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; by Medtronic Xomed, Inc.. Reason: Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead .
Details
Source
Device Recall
External ID
Z-1623-2025
Action Date
2025-04-30
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: All NIM Vital Nerve Monitoring Systems manufactured or installed with software version v1.6.4 or earlier. REF/UDI-DI: NIM4CM01/763000002978, 00763000395896, 00763000401597, 00763000528577; NIM4CM01RF/00763000002992; NIM4CPB1/763000002985, 00763000401603, 00763000395902, 00763000528584; NIM4CPB1RF/00763000003005; NIM4SWU143/00763000709341, 00763000869823; NIM4SWU154/00763000945398; NIM4SWU164/00763000974312
Quantity Affected: 9,788
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, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-10
Company
Jacksonville, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Xomed, Inc. has 19 FDA actions in our database, including 15 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Xomed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Xomed, Inc. have FDA actions?
Medtronic Xomed, Inc. has 19 FDA actions in our database, including 15 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1623-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29