NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF:
FDA device recall Z-1623-2025 · posted 2025-04-18 · Open, Classified
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- 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.
- Action taken
- 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 neuro.quality@medtronic.com 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.
- Root cause
- Software change control
- Status
- Open, Classified
- Product code
- GWF
- Quantity affected
- 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
- Date initiated
- 2025-03-10
- Date posted
- 2025-04-18
- Location
- Jacksonville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NIM Vital, Nerve Integrity Monitor (K200759) | Medtronic Xomed, Inc. | 2020-10-28 |