WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Broc
Summary
The FDA issued a Class II for WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop S by WAVi Co.. 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..
Details
Source
Device Recall
External ID
Z-1942-2024
Action Date
2024-06-12
Status
Ongoing
Category
device
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).
Lot/Code Info: Desktop software version 1.0.0.2
Quantity Affected: 281
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-08
Company
Denver, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 212 device recalls issued in the same week, part of 403 device-related FDA actions this month.
WAVi Co. has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (WAVi Co.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does WAVi Co. have FDA actions?
WAVi Co. has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1942-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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