FDAFDA · Food and drugs·Recall number Z-1942-2024
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).
Published June 12, 2024 · Recall initiated: December 8, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- WAVi Co.
- Distributor
- 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
- Desktop software version 1.0.0.2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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