Medical Device Recall: 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
RONAN MEDICAL LLC · December 11, 2023
Reason for Recall
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
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.
Distribution
Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
States Affected
NATIONWIDE
Quantity Affected
12
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2737-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.