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U.S. Department of Health and Human Services

Class 2 Device Recall Nicolet EEG Wireless Amplifier

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 Class 2 Device Recall Nicolet EEG Wireless Amplifier see related information
Date Posted March 13, 2013
Recall Status1 Terminated 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
608-8298655
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GWL and Original Applicant = CAREFUSION 209, INC.
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