Recall Z-2737-2024 ยท HCC Device, Biofeedback
RONAN MEDICAL LLC
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.
| Date | Aug 27, 2024 (initiated Dec 11, 2023) |
| Status | Open, Classified |
| Reason | Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended. |
| Root cause | Device Design |
| Action | Starting on 12/11/23, the firm telephoned customers and informed them that affected devices were being withdrawn and replaced. |
| Quantity | 12 |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.