RONAN MEDICAL LLC recalls BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to t…

Recall date

December 11, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2737-2024

FDA classification

Class II

Brand / firm

RONAN MEDICAL LLC

Sold / distributed

Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.

Why it was recalled

Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.