Class II — The Magstim Company Limited
| Recalling firm | The Magstim Company Ltd. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| 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. |
| Quantity | 7 units |
| Distribution | MN, NC, and NY |
| Initiated | 2020-12-08 |
| Classified | 2021-01-15 |
| Terminated | 2023-02-16 |
| Recall number | Z-0869-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — The Magstim Company Limited (Z-0869-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87063/
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