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WAVi Co. recalls WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Broc
Recalled June 12, 2024 · FDA recall Z-1942-2024 · WAVi
Hazard
Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study. · FDA Class II
Units
281
Sold at
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
Description
Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
Product
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).
Manufacturer(s)
WAVi Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →