Recall Z-1224-2022 ยท GWF Stimulator, Electrical, Evoked Response
Medtronic Xomed, Inc.
NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
| Date | Jun 2, 2022 (initiated May 3, 2022) |
| Status | Open, Classified |
| Reason | Software anomaly was identified. |
| Root cause | Software Design Change |
| Action | The firm issued a recall notification to consignees on 05/03/2022 via mail. The letter instructs the consignee to follow the IFU regarding the setup and "Lead Off Detected" error message, forward the notification to those who need to be aware within the organization and to any location which the devices have been distributed, and to complete the response form. An additional correction notification was sent on about 09/13/2023 to notify consignees of the update availability (NIM Vital" SW version v1.4.3) to fix this issue. |
| Quantity | 29 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France. |
| 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 |