FDAFDA · Food and drugs·Recall number Z-2737-2024
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.
Published September 4, 2024 · Recall initiated: December 11, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- RONAN MEDICAL LLC
- Distributor
- Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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