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U.S. Department of Health and Human Services

Class 2 Device Recall IPortal NOTC and VNG

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  Class 2 Device Recall IPortal NOTC and VNG see related information
Date Initiated by Firm April 30, 2015
Date Posted June 12, 2015
Recall Status1 Terminated 3 on April 17, 2017
Recall Number Z-1795-2015
Recall Event ID 71264
510(K)Number K083603  
Product Classification Nystagmograph - Product Code GWN
Product I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.
Code Information Model Numbers NOTC-S, NOTC-P, NOTC-C, NOTC-O, SVNG-1, SVNG-2, SVNG-3   
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		 complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.
FDA Determined
Cause 2		 Software design
Action Neuro Kinetics sent a Field Correction Advisory letter dated April 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with the affected product were instructed to contact Customer Service if a malfunction is encountered and not to use the device until it has been assessed and corrected by Nuerokinetics. Customers with questions should call 412-963-6649.
Quantity in Commerce 140
Distribution Worldwide distribution - US (nationwide) and Internationally to Canada and Mexico.
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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