Recall Z-2737-2024
Ronan Medical LLC · initiated December 11, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
Reason for recall
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
FDA-determined cause: Device Design
Action taken
Starting on 12/11/23, the firm telephoned customers and informed them that affected devices were being withdrawn and replaced.
Details
- Recall number
- Z-2737-2024
- Initiated
- December 11, 2023
- Posted by FDA
- August 27, 2024
- Product code
- HCC – Device, Biofeedback
- Quantity
- 12
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
- Recalling firm
- Ronan Medical LLC, Colorado Springs, CO