# FDA recall Z-1942-2024

> **WAVi Co.** · Class II · device recall initiated 2023-12-08.

## 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 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

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

## Key facts

- **Recall number:** Z-1942-2024
- **Recalling firm:** WAVi Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-08
- **Report date:** 2024-06-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Denver, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1942-2024

## Citation

> AI Analytics. FDA recall Z-1942-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1942-2024. Source: US FDA. Licensed CC0.

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