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U.S. Department of Health and Human Services

Class 2 Device Recall Neurosign 100

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  Class 2 Device Recall Neurosign 100 see related information
Date Initiated by Firm December 08, 2020
Create Date January 15, 2021
Recall Status1 Terminated 3 on February 16, 2023
Recall Number Z-0869-2021
Recall Event ID 87063
510(K)Number K923056  
Product Classification Stimulator, nerve - Product Code ETN
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.
Code Information Serial Numbers: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537
Recalling Firm/
Manufacturer		 The Magstim Company Limited
Spring Gardens
Whitland United Kingdom
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by email on 12/08/2020. The letter explained the issue, requested the consignee examine the device to confirm that the voltage setting and the fuse ratings are correct.. Should there be a mismatch, the consignee is to discontinue use and notify Magstim Service Department at service@magstim.com or by telephone +44 (0) 199401241111. The firm will send a service pack for the instrument.
Quantity in Commerce 7 units
Distribution MN, NC, and NY
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ETN and Original Applicant = THE MAGSTIM COMPANY LTD.
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