Z-0526-2013Class II

EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation

Name: Z-0526-2013 EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
Creator: EEG Info
Published: 2012-11-15
License: https://open.fda.gov/license/

EEG Info / initiated 2012-11-15 / Terminated / root cause: labeling and UDI

FDA source

EEG Info began a recall of EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation on 2012-11-15. FDA classified it as Class II and gives the reason as "EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0526-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-15
Posted: 2012-12-17
Terminated: 2013-06-11
Recalling firm: EEG Info
Product: EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
Product code: HCC Device, Biofeedback
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.
Root cause tag: labeling and UDI
FDA 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 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
Product codes and lots: Serial Number: 0001-3343.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0526-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0526-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-17

Product code HCC

K073557Class IIEEG Neuroamp, Model Cs10137Corscience GmbH & Co. KG / cleared 2008-02-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)