FDA Medical Device Recalls (openFDA)
WAVi Co.: 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 number
- Z-1942-2024
- Recalling firm
- WAVi Co.
- 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).
- Status
- Open, Classified
- Initiated
- 2023-12-08
- Posted
- 2024-05-31
- Terminated
- not on file
- Reason
- Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
- Root cause
- No Marketing Application
- Action
- 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 wavi@wavimed.com
- Quantity
- 281
- 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
- Lot, serial or model codes
- Desktop software version 1.0.0.2
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GWQ
- Firm FEI
- 3013757456
- Firm city
- Denver
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28