BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory sig...
FDA Recall #Z-2737-2024 — Class II — December 11, 2023
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.
Reason for Recall
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Recalling Firm
RONAN MEDICAL LLC — Colorado Springs, CO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
12
Distribution
Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
Code Information
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated