Denver, CO, United States
WAVi Co. recalls
1 recall recorded since 2018, most recently on 8 December 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 December 2023
- 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.
- 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
- Initiated
- Voluntary: Firm initiated
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.