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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94498

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 08, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
WAVi Co.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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).

Z-1942-2024
Recall number
Z-1942-2024
Initiated
December 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
WAVi Co.
Quantity
281

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

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Inspect official wording and provenance

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.

Code information

Desktop software version 1.0.0.2

Distribution pattern

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