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Recall Observatory FDA recall evidence

Device 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).

Z-1942-2024

December 08, 2023

Class II

Product summary

Firm
WAVi Co.
Event
Event 94498
Status
Ongoing
Classification
Class II
Quantity
281
Official record key
device-enforcement:Z-1942-2024

Official wording

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.

Code information: Desktop software version 1.0.0.2

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.