Colorado Springs, CO, United States
RONAN MEDICAL LLC recalls
1 recall recorded since 2018, most recently on 11 December 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 11 December 2023
- Reason
- Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
- Initiated
- Voluntary: Firm initiated
- 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 p
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.