Recall Z-0869-2021— The Magstim Company Limited

Name: FDA recall Z-0869-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-08

Class II · Terminated

Class II FDA medical device recall by The Magstim Company Limited, initiated 2020-12-08, terminated 2023-02-16. It names one FDA 510(k) clearance: K923056. 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: 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..

Recalling firm: The Magstim Company Limited
Classification: Class II
Status: Terminated
Initiated: 2020-12-08
Terminated: 2023-02-16
Firm location: Whitland, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K923056 — NEUROSIGN MODEL 100The Magstim Company , Ltd.·cleared 1992-11-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.