Recall Z-1623-2025 ยท GWF Stimulator, Electrical, Evoked Response
Medtronic Xomed, Inc.
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:
| Date | Apr 18, 2025 (initiated Mar 10, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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, a |
| Quantity | 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 Al |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200759 | NIM Vital, Nerve Integrity Monitor Medtronic Xomed, Inc., Oct 28, 2020 |