EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
FDA Recall Z-0526-2013 · Posted 2012-12-17
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Recalling FirmEEG Info
Recall StatusTerminated
Product CodeHCC
Date Initiated2012-11-15
Date Terminated2013-06-11
Product Quantity1308 units
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.
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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