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Open, Classified

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).

FDA Recall Z-1942-2024 · Posted 2024-05-31

Recalling FirmWAVi Co.
Recall StatusOpen, Classified
Product CodeGWQ
Date Initiated2023-12-08
Product Quantity281

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.

Firm 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 [email protected]

Root Cause

No Marketing Application

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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