EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
FDA device recall Z-0526-2013 · posted 2012-12-17 · Terminated
Recall details
- Recalling firm
- EEG Info
- 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 taken
- 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
- Status
- Terminated
- Product code
- HCC
- Quantity affected
- 1308 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2012-11-15
- Date posted
- 2012-12-17
- Date terminated
- 2013-06-11
- Location
- Woodland Hills, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EEG NEUROAMP, MODEL CS10137 (K073557) | Corscience GmbH & Co. KG | 2008-02-28 |