Use caution Medical device recall · FDA · Published December 8, 2020

Magstim Neurosign 100 Intraoperative Nerve Monitor: Voltage Configuration Hazard

Magstim recalls Neurosign 100 nerve monitors with incorrect voltage settings for US/Canada use. These may cause electrical issues if connected to 120V power. Affected units have specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0869-2021Medical device Magstim ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmThe Magstim Company LimitedSpring Gardens · Whitland, United Kingdom

✎ GovInfoNow plain-language explainer

Magstim is recalling certain Neurosign 100 intraoperative nerve monitors that may have been shipped without proper voltage configuration for US and Canadian power systems. This could lead to electrical problems if used with standard 120V outlets. Read more at govinfonow.com/recall/63709-magstim-neurosign-100-intraoperative-nerve-monitor-voltage-configuration-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/63709-magstim-neurosign-100-intraoperative-nerve-monitor-voltage-configuration-hazard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0869-2021

Cite this page

“Magstim Neurosign 100 Intraoperative Nerve Monitor: Voltage Configuration Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63709-magstim-neurosign-100-intraoperative-nerve-monitor-voltage-configuration-hazard. Based on FDA recall #Z-0869-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0869-2021%22&limit=1).

The FDA announced on Dec. 8, 2020, that The Magstim Company Limited voluntarily recalled seven Neurosign 100 Intraoperative Nerve Monitors (Product Number 9883-01) due to incorrect voltage configuration and fuse specifications.

How to tell if you have it

Brand: Magstim
Product: Neurosign 100 Intraoperative Nerve Monitor, Product Number 9883-01
Serial Numbers: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537
Units affected: 7
Sold in: MN, NC, NY

The hazard

According to the FDA, a small number of units may have been dispatched with the onboard voltage selector set to 240V instead of the 120V requirement for the United States and Canada. Additionally, the power entry module fuses were installed as 2xT315mAL (240V Standard) rather than the required 2xT630mAL for a 120V mains supply.

Context

GovInfoNow's records show The Magstim Company Limited has four other recalls on record since Sept. 28, 2017. On June 23, 2020, the company issued a recall for the Neurosign V4 Nerve Monitor due to cable damage risk. On March 23, 2020, a recall was announced for the Rapid2 PSU Stim Interconnecting Cable regarding high voltage failure risk. Other recent recalls of similar products include the Magstim HORIZON Ez Arm Recall (Oct. 25, 2018) involving stray cable risk.

How to tell if you have this one

Check if your Neurosign 100 has a serial number from the list: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537. The device is used during ENT surgeries to monitor facial nerves.

Brand
Magstim
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Verify your Neurosign 100's serial number against the list: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537.

Where it went and when

Where it was distributed

Distributed in 3 states.

FDA distribution: “MN, NC, and NY” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Minnesota, New York, North Carolina.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Dec 8, 2020Firm started the recall
Jan 15, 2021FDA classified it Class II
Jan 27, 2021Published in FDA’s Enforcement Report
Feb 16, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63709-magstim-neurosign-100-intraoperative-nerve-monitor-voltage-configuration-hazard">Magstim Neurosign 100 Intraoperative Nerve Monitor: Voltage Configuration Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0869-2021 (December 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0869-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.