BrainFeedback Pro 2 Device — Class II medical device recall Z-2737-2024
Ongoing recall by RONAN MEDICAL LLC, reported 2024-09-04, distributed nationwide. Neurofeedback systems removed due to missing design and development documentation and devices may not perform
| Recall number | Z-2737-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RONAN MEDICAL LLC, Colorado Springs, CO, United States |
| Recall initiated | 2023-12-11 |
| Classified | 2024-08-27 |
| Reported by FDA | 2024-09-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | IN |
| Quantity | 12 |
| UPC / GTIN / UDI-DI | 08592566001017, 08592566001123 |
| Serial numbers | ACBFB12-1911003, ACBFB12-2004012, ACBFB12-2004014, ACBFB12-2105001, ACBFB12-2105002, ACBFB12-2105004, ACBFB12-2105005, ACBFB12-2109005, ACBFB12-2109006, ACBFB12-2109007, ACBFB12-2109008, ACBFB12-2301024 |
Product
BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control voluntarily these physiological parameters.
Reason for recall
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2737-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.