Z-1942-2024Class II

WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction...

Name: Z-1942-2024 WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction...
Creator: WAVi Co.
Published: 2023-12-08
License: https://open.fda.gov/license/

WAVi Co. / initiated 2023-12-08 / Open, Classified

FDA source

WAVi Co. began a recall of WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV)... on 2023-12-08. FDA classified it as Class II and gives the reason as "Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1942-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-08
Posted: 2024-05-31
Recalling firm: WAVi Co.
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).
Product code: GWQ Full-Montage Standard Electroencephalograph
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.
FDA root cause: No Marketing Application
Action: On 12/8/23, notices were emailed to customers informing them that the research study was being closed so the affected systems should be returned. The study sponsor would contact customers to help facilitate return. Customers with questions could reply to the email sent from [email protected]
Quantity in commerce: 281
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
Product codes and lots: Desktop software version 1.0.0.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1942-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1942-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-05-31

Product code GWQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)