FDA recall Z-2737-2024

RONAN MEDICAL LLC · Class II · device

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 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.

Key facts

Status
Ongoing
Initiation date
2023-12-11
Report date
2024-09-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Colorado Springs, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2737-2024