Recall Z-2409-2024 ยท GWF Stimulator, Electrical, Evoked Response
Medtronic Xomed, Inc.
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATI
| Date | Jul 24, 2024 (initiated Jun 24, 2024) |
| Status | Open, Classified |
| Reason | Potential for false negative response on the NIM Vital Nerve Monitoring System |
| Root cause | Under Investigation by firm |
| Action | Medtronic Xomed notified consignees on 06/24/2024 via letter. The letter instructed consignees that Medtronic has developed a NIM" Vital software version 1.5.4 to address this issue. Consignees were also instructed to identify affected products within inventory, 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, and maintain a copy of this letter for your records. The respective Medtronic Representative will contact you to install the new software |
| Quantity | 7,804 units |
| Distribution | Worldwide distribution - US Nationwide 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, Finla |
| 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 |