Reported Sep 4, 2024 · Ongoing
BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to…
Ronan Medical LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RONAN MEDICAL LLC · 3225 International Cir Ste 100 · Colorado Springs, CO · 80910-3161
Is this the product you have?
- 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.
- Lot codes and dates
- UDI-DI
0859256600101708592566001123
- Serial Numbers
ACBFB12-1911003ACBFB12-2004012ACBFB12-2004014ACBFB12-2105001ACBFB12-2105002ACBFB12-2105004ACBFB12-2105005ACBFB12-2109005ACBFB12-2109006ACBFB12-2109007ACBFB12-2109008ACBFB12-2301024
- UDI-DI
- Amount recalled
- 12
Where it was sold
Why it was recalled
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
This product could cause temporary or reversible health problems — stop using it.
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