The Magstim Company Limited Recall 87063
Description: Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures.
The Magstim Company Limited Recall 87063 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0869-2021 |
| Event ID | 87063 |
| Event Description | Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures. |
| Product Type | Devices |
| Distribution | MN, NC, and NY |
| Quantity | 7 units |
| Recall Reason | A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the target Country. The specific deficiency includes: 1. Onboard voltage selector set to 240V (European Standard), versus 120V requirement for the United States and Canada. 2. Fuses installed in the Power Entry Module (PEM) 2xT315mAL (240V Standard), versus the 2xT630mAL requirement for a 120V mains supply. |
| Device Classification | 20210127 |
| Device Code Info | Serial Numbers: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537 |
| Center Classification Date | 20210115 |
| Recall Initiation Date | 20201208 |
| Recalling Firm | The Magstim Company Limited |
| Initial Notification | |
| Similar To |