FDA Device recall Z-1942-2024
WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rat…
- FDA Device
- Class II
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class II recall of WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rat… by Wavi, citing following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1942-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-08 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Wavi |
| Distribution | AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NM, NV, NY, OH, OR, PA, TX, UT, VA, WA |
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).
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.
Identifiers
| code_info | Desktop software version 1.0.0.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1942-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.