Medical Device Recall: 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 incorporat
WAVi Co. · December 8, 2023
Reason for Recall
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 Description
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).
Distribution
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
States Affected
AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NM, NV, NY, OH, OR, PA, TX, UT, VA, WA
Quantity Affected
281
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1942-2024
Status: ongoing
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