WAVi Co. is recalling approximately 281 units of the WAVi Research EEG Desktop System, which includes desktop software (version 1.0.0.2), instruction manuals, Heart Rate Variability (HRV) ear clips, and associated headsets and electrodes. This recall was initiated following an FDA-issued Warning Letter and the subsequent closure of the firm's research study. The manufacturer has requested the return of all research EEG system components that were distributed across 31 U.S. states.
The recall was prompted by regulatory concerns cited in an FDA Warning Letter and the termination of a research study, which may mean the device's safety and effectiveness for its intended research use have not been fully established or maintained under required regulatory standards.
Return of research EEG system components
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.