Recall Z-2737-2024— RONAN MEDICAL LLC
Class II · Ongoing
Class II FDA medical device recall by RONAN MEDICAL LLC, initiated 2023-12-11. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended..
- Recalling firm
- RONAN MEDICAL LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-11
- Firm location
- Colorado Springs, CO, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.