Z-1942-2024 Class II Ongoing
FDA device recall Z-1942-2024 was initiated by WAVi Co. on December 8, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 281.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2024
- Initiation Date
- December 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 281
Product Description
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).
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.
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
Code Information
Desktop software version 1.0.0.2