WAVi Co. recalls WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Bro…

Recall date

December 8, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1942-2024

FDA classification

Class II

Brand / firm

WAVi Co.

Sold / distributed

US: NC, TX, IL, NV, AZ, NY, CA, MI, KS, AL, FL, MD, UT, WA, PA, GA, AR, NM, CO, IA, CT, IN, VA, LA, HI, MA, OH, OR, MO, KY, ID

Why it was recalled

Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporates use of the firm's cleared EEG analysis technology (the WAVi SCAN EEG System and Accessories, and the WAVi Headset and eSoc Single Use Electrode Contacts).