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

FDA Recall #Z-1942-2024 — Class II — December 8, 2023

Recall #Z-1942-2024 Date: December 8, 2023 Classification: Class II Status: Ongoing

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.

Recalling Firm

WAVi Co. — Denver, CO

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

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

Code Information

Desktop software version 1.0.0.2

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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