Class II — RONAN MEDICAL LLC
| Recalling firm | Ronan Medical |
|---|---|
| Registered facility | RONAN MEDICAL LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended. |
| 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. |
| Quantity | 12 |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India. |
| Initiated | 2023-12-11 |
| Classified | 2024-08-27 |
| Recall number | Z-2737-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — RONAN MEDICAL LLC (Z-2737-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95089/
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