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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
EEG NeuroAmp		see related information
Date Posted December 17, 2012
Recall Number Z-0526-2013
Product EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
Code Information Serial Number: 0001-3343.
Recalling Firm/
Manufacturer		 EEG Info
6400 Canoga Ave
Suite 210
Woodland Hills, California 91367-2425
Reason for
Recall		 EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices.
Action EEGInfo sent a recall notification letterdated November 29, 2012, to all affected customers. The letter informed the customers they have not received approval from the FDA to market and distribute a device for therapeutic applications other than that of its FDA intended use-biofeedback relaxation. Customers are informed that the safety and effectiveness for other indications has not been established. The risk or likelihood of serious adverse health consequences is remote. Customers were instructed to forward this notice if affected product was further distributed. Customers with questions about the notification letter are instructed to contact EEG Info's customer support line during normal business hours, Monday-Friday, from 8am-5pm PST. For questions regarding this recall call 818-456=5965.
Quantity in Commerce 1308 units
Distribution Nationwide Distribution
 
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