The Magstim Company Limited: Medical Device Recall in 2021 - (Recall #: Z-0869-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 8, 2020

Date Posted: January 27, 2021

Recall Number: Z-0869-2021

Event ID: 87063

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.

Status: Terminated

Product Quantity: 7 units

Code Information:

Serial Numbers: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537

Distribution Pattern:

MN, NC, and NY

Voluntary or Mandated:

Voluntary: Firm initiated