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

Hazard

Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.

Details from the source

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. Quantity: 12 Lot/code info: UDI-DI: 08592566001017, 08592566001123, Serial Numbers: ACBFB12-1911003, ACBFB12-2004012, ACBFB12-2004014, ACBFB12-2105001, ACBFB12-2105002, ACBFB12-2105004, ACBFB12-2105005, ACBFB12-2109005, ACBFB12-2109006, ACBFB12-2109007, ACBFB12-2109008, ACBFB12-2301024

UPC codes

08592566001017, 08592566001123

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.