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U.S. Department of Health and Human Services

Class 2 Device Recall XLTEK EMU40EX EEG Headbox

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  Class 2 Device Recall XLTEK EMU40EX EEG Headbox see related information
Date Initiated by Firm May 15, 2018
Create Date July 28, 2018
Recall Status1 Terminated 3 on May 06, 2024
Recall Number Z-2570-2018
Recall Event ID 80239
510(K)Number K039654  
Product Classification Full-montage Standard Electroencephalograph - Product Code GWQ
Product XLTEK EMU40EX EEG Headbox
Code Information Part Numbers: 10406, 002933
Recalling Firm/
Manufacturer		 Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
2568 Bristol Cir
Oakville Canada
Manufacturer Reason
for Recall		 Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout box to fail. It may feel hot and plastic case may start melting.
FDA Determined
Cause 2		 Other
Action Natus Neurology notified customers on or about 05/15/2018, via Advisory Notification Letter to stop using the device immediately and contact Natus regarding replacement options. Customers were advised that if the malfunction occurs, to immediately cease using the device and contact Natus for replacement. Customers were also instructed to communicate the notification to all applicable users and to complete and return the advisory verification form.
Quantity in Commerce 462 Units Total
Distribution USA Distribution: AL, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, ,RI, SC, TN, TX, UT, VA, WA, WI. World wide Distribution: Canada, China, Cyprus, Germany, Hong Kong, Italy, Mexico, Saudi Arabia, Spain, United Kingdom
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.
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