Recall Z-0869-2021 ยท ETN Stimulator, Nerve
The Magstim Company Limited
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.
| Date | Dec 8, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | The firm initiated the recall by email on 12/08/2020. The letter explained the issue, requested the consignee examine the device to confirm that the voltage setting and the fuse ratings are correct.. Should there be a mismatch, the consignee is to discontinue use and notify Magstim Service Department at service@magstim.com or by telephone +44 (0) 199401241111. The firm will send a service pack for the instrument. |
| Quantity | 7 units |
| Distribution | MN, NC, and NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923056 | NEUROSIGN MODEL 100 The Magstim Company , Ltd., Nov 24, 1992 |