Home / Recalls / RONAN MEDICAL LLC / Z-2737-2024

Z-2737-2024 Class II Ongoing

Recalled by RONAN MEDICAL LLC — Colorado Springs, CO

Recall Details

Product Type: Devices
Report Date: September 4, 2024
Initiation Date: December 11, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12

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.

Distribution Pattern

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