• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Nicolet EEG Wireless Amplifier

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Nicolet EEG Wireless Amplifier see related information
Date Initiated by Firm February 27, 2013
Date Posting Updated March 13, 2013
Recall Status1 Terminated 3 on April 25, 2014
Recall Number Z-0946-2013
Recall Event ID 64479
510(K)Number K103140  
Product Classification Amplifier, physiological signal - Product Code GWL
Product Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier.

Product Usage:
The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.
Code Information C110318004, C110318027, C110815014, C110815025, C110519011, C110318029, C110318010, C110318028, C110318030, C110318019, C110318006, C110318013, C110519022, C110519021, C110323024, C110323039, C110323037, C110323034, C110519003, C110323011, C110323007, C110815003, C110323040, C110815030, C110815015, C110517040, C110815026, C110519031, C110519030, C110513015 , , C110519035, C110318009, C110815020, C110519023, C110519023, C110815001, C110519010, C110519017, C110318018, 61855, C110519002, C110323006, 38249, , C110815007, C110323036 , C110519007, C110519012, C110519027, C110318008, C110318016, C110318026, C110318027, C110519008, C110519009, C110815023, C110815013, C110519034, C110519029, C110323050 , C110118018, C110519043, C110815027, C110519005, C110519026, C110579013, C110519045, C110519015 , C110201021, C110318001, , C110519050, C110323002, C110519014, C110519033, C110318012, C110519038, C110519042, C110318023, C110519020, RG100512M, C110519046, C110519037, C110519019, C110519007, C110318016, C110318002, C110815016, C110815012, RC110125M, C110323018, C110815024, A4312 & A4314, C110318014, C110318011, C110318015, 34902, C110815011, C110309001, C110519002, A42A0, C110318025, C110519036, C110519028, C110519024, C110519013, C110318005



Recalling Firm/
Manufacturer
Natus Neurology Incorporated
1850 Deming Way
Middleton WI 53562-3530
For Additional Information Contact
608-8298655
Manufacturer Reason
for Recall
Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Natus sent an "Urgent Medical Device Correction and Removal Notification' letter dated February 27, 2013 to all affected customers. The letter described the affected product, problem and actions to be taken. The letter advised customers that a Natus Field Service technician will remove and replace the affected product at no charge to the users. The letter also advised if any of the affected products have been transferred to another location to please forward a copy of the letter and to notify Natus. For questions call 800-356-0007 ext. 5129.
Quantity in Commerce 114 (31 USA; 83 OUS)
Distribution Worldwide Distribution - USA Nationwide including the states of CA, FL, LA, MD, MS, MO, NJ, NY, PA, TX and the country of AUSTRALIA. BAHRAIN BRAZIL CANADA Country DENMARK EGYPT GERMANY HONG KONG INDIA INDONESIA IRELAND ITALY JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS ROMANIA RUSSIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM URUGUAY VIET NAM
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 = GWL and Original Applicant = CAREFUSION 209, INC.
-
-