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.
Reported: September 4, 2024 Initiated: December 11, 2023 #Z-2737-2024
Product Description
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.
Reason for Recall
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Details
- Recalling Firm
- RONAN MEDICAL LLC
- Units Affected
- 12
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
- Location
- Colorado Springs, CO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by RONAN MEDICAL LLC. Units affected: 12.
Why was this product recalled? ▼
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 4, 2024. Severity: Moderate. Recall number: Z-2737-2024.
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