BrainFeedback Pro 2 Device (Ronan) – Performance Documentation Issue (2023)
Neurofeedback system may not perform as intended due to missing documentation.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
RONAN MEDICAL LLC
Lot Codes / Batch 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
Products Sold
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
RONAN MEDICAL LLC is recalling BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal due to Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Recommended Action
Per FDA guidance
Starting on 12/11/23, the firm telephoned customers and informed them that affected devices were being withdrawn and replaced.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026