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RONAN MEDICAL LLC recalls BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to th
Recalled September 4, 2024 · FDA recall Z-2737-2024 · RONAN MEDICAL
Hazard
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended. · FDA Class II
Units
12
Sold at
Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
Description
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.
Manufacturer(s)
RONAN MEDICAL LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →