RONAN MEDICAL LLC is recalling 12 units of the BrainFeedback Pro 2 Device because the systems are missing critical design and development documentation. This neurofeedback instrument, which provides visual and auditory signals to help patients voluntarily control physiological parameters, may not perform as intended due to these missing specifications. The affected devices were distributed in California, Florida, Tennessee, Michigan, Illinois, Connecticut, and India.
The lack of design documentation means the devices may fail to provide accurate physiological feedback, which could lead to ineffective treatment or improper patient response during neurofeedback sessions.
Manufacturer-initiated removal and contact for instructions.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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