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U.S. Department of Health and Human Services

Class 2 Device Recall Normative Data Template CD

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  Class 2 Device Recall Normative Data Template CD see related information
Date Initiated by Firm November 21, 2013
Date Posted February 10, 2014
Recall Status1 Terminated 3 on July 20, 2015
Recall Number Z-0966-2014
Recall Event ID 66995
510(K)Number K083603  
Product Classification Nystagmograph - Product Code GWN
Product Normative Data Template CD for use with the I-Portal devices.

Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.
Code Information Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1
Recalling Firm/
Manufacturer		 Neuro Kinetics, Inc.
128 Gamma Dr
Pittsburgh PA 15238-2920
For Additional Information Contact Customer Support
412-963-6649
Manufacturer Reason
for Recall		 The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.
FDA Determined
Cause 2		 No Marketing Application
Action A recall notification letter, dated November 2013, was sent to Users. A follow up letter regarding scheduling removal of the software is planned for December 2013.
Quantity in Commerce 148
Distribution Distributed USA (nationwide) and the country of 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 = GWN and Original Applicant = NEURO KINETICS
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