Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Neurosign 100 Recalled by The Magstim Company Limited Due to A small number of Neurosign 100 Intraoperative Nerve...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact The Magstim Company Limited directly.
Affected Products
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
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 3 states: MN, NY, NC
About The Magstim Company Limited
The Magstim Company Limited has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report