FDA Device recall Z-0869-2021
Neurosign 100, Product Number 9883-01
- FDA Device
- Class II
- terminated
- Published 2021-01-27
On 2021-01-27 the FDA classified a Class II recall of Neurosign 100, Product Number 9883-01 by The Magstim, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0869-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-08 |
| Published | 2021-01-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | The Magstim |
| Distribution | MN, NC, NY |
Product
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.
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.
Identifiers
| code_info | Serial Numbers: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0869-2021%22
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