BrainFeedback Pro 2 Device - is intended as an instrument… recallZ-2737-2024 · Ronan Medical LLC · initiated Dec 11, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ronan Medical LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
FDA root cause category: Device Design
What the company is doing
Starting on 12/11/23, the firm telephoned customers and informed them that affected devices were being withdrawn and replaced.
Recall details
- Recall number
- Z-2737-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 11, 2023
- Posted by the FDA
- Aug 27, 2024
- Recalling firm
- Ronan Medical LLC
- Quantity
- 12
- Product code
- HCC
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
Product description
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BrainFeedback Pro 2 BF-PRO2DEYMED Diagnostic s.r.o. · Device, Biofeedback1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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