Reported Jun 12, 2024 · Ongoing
WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and…
WAVi Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: WAVi Co. · 3857 N Steele St Ste 1293 · Denver, CO · 80205-4996
Is this the product you have?
- 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).
- Lot codes and dates
- Desktop software version 1.0.0.2
- Amount recalled
- 281
Where it was sold
Why it was recalled
Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
This product could cause temporary or reversible health problems — stop using it.
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