Device evidence

device-recall:cfres:209436

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.

Official recall number

Z-2737-2024

Evidence summary

Product code: HCC
Recall status: Open, Classified
Event initiated: December 11, 2023
Root cause: Device Design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2737-2024