The Magstim Company Limited recalls Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating a…

Recall date

December 8, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0869-2021

FDA classification

Class II

Brand / firm

The Magstim Company Limited

Sold / distributed

MN, NC, and NY

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.