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U.S. Department of Health and Human Services

Class 2 Device Recall Neuro Works

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  Class 2 Device Recall Neuro Works see related information
Date Initiated by Firm November 11, 2015
Create Date January 04, 2016
Recall Status1 Terminated 3 on October 03, 2016
Recall Number Z-0581-2016
Recall Event ID 72763
510(K)Number K143440  
Product Classification Full-montage Standard Electroencephalograph - Product Code GWQ
Product Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926.

The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.
Code Information Serial Number 013926020008 013926020009 013926020006 013926020016 013926020014 013926030024 013926030031 013926020001 013926020004 013926030059 013926030060 013926030074 013926030075 013926030052 013926030017 013926030018 013926030021 013926030053 013926030101 013926030058 013926030019 013926030038 013926030039 013926030044 013926020015 013926030097 013926020013 013926030055 013926030056 013926030081 013926030096 013926030078 013926030048 013926030057 013926030064 013926030047 013926030027 013926030025 013926030042 013926030023 013926030030 013926030036 013926030026 013926030050 013926030080 013926030099 013926030035 013926030046 013926030049 013926030073 013926030020 013926030092 013926030040 013926030041 013926030061 013926030062 
Recalling Firm/
Manufacturer		 Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
2568 Bristol Cir
Oakville Canada
For Additional Information Contact Sanjay Mehta
905-287-5055
Manufacturer Reason
for Recall		 During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action The firm, Natus Neurology, sent an "Urgent Medical Device Correction Notification" letter on 11/11/2015. The letter described the the problem, the product involved in the recall and actions to be taken. Natus will provide further information once an updated software is released. The consignees were instructed to complete and return the confirmation form by mail to Senior Manager Quality and Regulatory Affairs, Excel-Tech, Ltd (XLTEK) Division, Natus Medical Incorporated, 2568 Bristol Circle, Oakville, ON L6H 5S1 or by email to :ots@natus.com. If you have any questions, contact Senior Manager Quality and Regulatory Affairs at 905-287-5055 or email: sanjay.mehta@natus.com.
Quantity in Commerce 56 (43 US, 13 OUS)
Distribution Worldwide Distribution: US Distribution including states of: AL, AZ, AR, CO, FL, GA, MD, MA, MN, MS, NJ, NY, OH, SC, TN, TX and UT; and countries of: INDIA, KOREA, SPAIN, SWITZERLAND, THAILAND, UNITED KINGDOM, and CANADA. .
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 = GWQ and Original Applicant = NATUS MEDICAL INCORPORATED
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