Recall Z-1942-2024 ยท GWQ Full-Montage Standard Electroencephalograph
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).
| Date | May 31, 2024 (initiated Dec 8, 2023) |
| Status | Open, Classified |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.