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U.S. Department of Health and Human Services

Class 2 Device Recall WAVi Research EEG Desktop System

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 Class 2 Device Recall WAVi Research EEG Desktop Systemsee related information
Date Initiated by FirmDecember 08, 2023
Date PostedMay 31, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1942-2024
Recall Event ID 94498
Product Classification Full-montage Standard Electroencephalograph - Product Code GWQ
ProductWAVi 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).
Code Information Desktop software version 1.0.0.2
FEI Number 3013757456
Recalling Firm/
Manufacturer		 WAVi Co.
3857 N Steele St Ste 1293
Denver CO 80205-4996
For Additional Information Contact
303-761-4447
Manufacturer 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 Determined
Cause 2		No Marketing Application
ActionOn 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 wavi@wavimed.com
Quantity in Commerce281
DistributionUS: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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