# FDA recall Z-0869-2021

> **The Magstim Company Limited** · Class II · device recall initiated 2020-12-08.

## 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 for recall

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.

## Distribution

MN, NC, and NY

## Key facts

- **Recall number:** Z-0869-2021
- **Recalling firm:** The Magstim Company Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-08
- **Report date:** 2021-01-27
- **Termination date:** 2023-02-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Whitland, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0869-2021

## Citation

> MORVS. FDA recall Z-0869-2021. Retrieved 2026-11-03 from https://api.morvs.ai/recall/Z-0869-2021. Source: US FDA. Licensed CC0.

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