Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated fo...
FDA Recall #Z-0869-2021 — Class II — December 8, 2020
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.
Recalling Firm
The Magstim Company Limited — Whitland, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
7 units
Distribution
MN, NC, and NY
Code Information
Serial Numbers: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated