Z-1623-2025Class II

NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0...

Name: Z-1623-2025 NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0...
Creator: Medtronic Xomed, Inc.
Published: 2025-03-10
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2025-03-10 / Open, Classified / root cause: software

FDA source

Medtronic Xomed, Inc. began a recall of NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1... on 2025-03-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1623-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-10
Posted: 2025-04-18
Recalling firm: Medtronic Xomed, Inc.
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
Product code: GWF Stimulator, Electrical, Evoked Response
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.
Root cause tag: software
FDA root cause: Software change control
Action: On 3/10/2025, recall notices were mailed, and/or emailed to customers who were asked to do the following: 1) Your Medtronic representative will contact you to install the new software version 1.7.5 for correction of the impacted product in your possession. 2) For patients who are currently being monitored with affected devices, be aware of the possibility of increased stimulus artifact. Refer to the system instructions for use for instructions on how the stimulus artifact may be reduced or exacerbated through the adjustment of system settings including event threshold, stimulation current, and rejection period. 3) Complete and return the customer confirmation form via email to [email protected] 4) Share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. Maintain a copy of this letter for your records. Distributors are asked to discard any of the items below in your inventory: a. SOFTWARE NIM4SWU143 UPGRADE v1.4.3 b. SOFTWARE NIM4SWU154 UPGRADE v1.5.4 c. SOFTWARE NIM4SWU164 UPGRADE v1.6.4 If you have any questions regarding this communication, please contact the firm's Sales Representative or Technical Services at 1-888-826-5603.
Quantity in commerce: 9,788
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1623-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1623-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-18

Product code GWF

K200759Class IINIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc. / cleared 2020-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)