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).
Recall
- Recall Number
- Z-1942-2024
- Event Number
- 94498
- Firm
- WAVi Co.
- FEI Number
- 3013757456
- Product Code
- GWQ
- Status
- Open, Classified
- Root Cause
- No Marketing Application
- Initiated
- December 8, 2023
- Posted
- May 31, 2024
- Address
- 3857 N Steele St, Ste 1293, Denver, CO, 80205-4996
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).
Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
On 12/8/23, notices were emailed to customers informing them that the research study was being closed so the affected systems should be returned. The study sponsor would contact customers to help facilitate return. Customers with questions could reply to the email sent from [email protected]
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
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