FDA Recall
Open, Classified
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.
Recall: Z-2737-2024
·
Initiated December 11, 2023
Recall
- Recall Number
- Z-2737-2024
- Event Number
- 95089
- Firm
- RONAN MEDICAL LLC
- FEI Number
- 3015497638
- Product Code
- HCC
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- December 11, 2023
- Posted
- August 27, 2024
- Address
- 3225 International Cir, Ste 100, Colorado Springs, CO, 80910-3161
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
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Action
Starting on 12/11/23, the firm telephoned customers and informed them that affected devices were being withdrawn and replaced.
Distribution
Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
Quantity
12