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Recall Observatory FDA recall evidence

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.

Z-2737-2024

December 11, 2023

Class II

Product summary

Firm
RONAN MEDICAL LLC
Event
Event 95089
Status
Ongoing
Classification
Class II
Quantity
12
Official record key
device-enforcement:Z-2737-2024

Official wording

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

Code information: 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

Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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