Recall Z-0526-2013 ยท HCC Device, Biofeedback
EEG Info
EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
| Date | Dec 17, 2012 (initiated Nov 15, 2012) |
| Status | Terminated |
| Reason | EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices. |
| Root cause | 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 question |
| Quantity | 1308 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073557 | EEG NEUROAMP, MODEL CS10137 Corscience GmbH & Co. KG, Feb 28, 2008 |