WAVi Research EEG Desktop System recalled due to FDA Warning Letter
WAVi Co. is recalling 281 units of the WAVi Research EEG Desktop System following an FDA-issued Warning Letter. The company requested the return of components due to closure of their research study.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall initiated following an FDA-issued Warning Letter, indicating regulatory non-compliance. While no illnesses or injuries are reported in the source documentation, this is a risk-of-harm medical device where injury has not yet been reported, warranting a High severity rating per the recall rubric.
Plain-English summary
WAVi Co. is recalling the WAVi Research EEG Desktop System, which comprises EEG desktop software, instruction manual, brochure, and Heart Rate Variability ear clips, along with the WAVi SCAN EEG analysis technology, WAVi Headset, and eSoc Single Use Electrode Contacts. A total of 281 units were distributed across the United States.
The recall was initiated following an FDA-issued Warning Letter. WAVi Co. requested the return of the research system components due to closure of the company's research study.
The recalled product
- 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…
- Manufacturer
- WAVi Co.
- Affected units
- 281
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Desktop software version 1.0.0.2
Distribution
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