Date Initiated by Firm | November 15, 2012 |
Date Posted | December 17, 2012 |
Recall Status1 |
Terminated 3 on June 11, 2013 |
Recall Number | Z-0526-2013 |
Recall Event ID |
63824 |
510(K)Number | K073557 |
Product Classification |
Device, biofeedback - Product Code HCC
|
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 CA 91367-2425
|
For Additional Information Contact | 818-456-5965 |
Manufacturer 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. |
FDA Determined Cause 2 | Labeling False and Misleading |
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 |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = HCC
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