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.
This recall is currently active, issued August 27, 2024. It was issued by Ronan Medical Llc.
- Company
- Ronan Medical Llc
- Recall Initiated
- December 11, 2023
- Posted
- August 27, 2024
- Recall Number
- Z-2737-2024
- Quantity
- 12
- Firm Location
- Colorado Springs, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Distribution
Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
Lot / Code Info
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
Root 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Starting on 12/11/23, the firm telephoned customers and informed them that affected devices were being withdrawn and replaced.