BrainFeedback Pro 2 neurofeedback device recalled for missing design documentation
RONAN MEDICAL LLC is recalling BrainFeedback Pro 2 neurofeedback devices due to missing design and development documentation. Devices may not perform as intended.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is missing design and development documentation that could result in device malfunction. This appears to be a precautionary, compliance-driven recall rather than a recall for a known dangerous defect.
Plain-English summary
RONAN MEDICAL LLC is recalling BrainFeedback Pro 2 neurofeedback devices (12 units) due to missing design and development documentation. The devices are intended to provide visual and auditory signals corresponding to a patient's physiological parameters, allowing patients to voluntarily control these parameters for biofeedback purposes.
Without proper design and development documentation, the devices may not perform as intended. The recalled units have specific serial numbers and were distributed nationwide in California, Florida, Tennessee, Michigan, Illinois, Connecticut, and internationally in India.
Patients who have received this device should contact RONAN MEDICAL LLC to discuss the recall and determine next steps. Affected healthcare providers should verify whether they have received affected units by checking the provided serial numbers and UDI codes.
The recalled product
- 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.
- Manufacturer
- RONAN MEDICAL LLC
- Hazard
- design-documentation
- malfunction-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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
Distributed nationwide across the United States.
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