FDA Medical Device Recalls (openFDA)
RONAN MEDICAL LLC: 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.
- Recall number
- Z-2737-2024
- Recalling firm
- RONAN MEDICAL LLC
- 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.
- Status
- Open, Classified
- Initiated
- 2023-12-11
- Posted
- 2024-08-27
- Terminated
- not on file
- Reason
- Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
- Root cause
- Device Design
- Action
- Starting on 12/11/23, the firm telephoned customers and informed them that affected devices were being withdrawn and replaced.
- Quantity
- 12
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HCC
- Firm FEI
- 3015497638
- Firm city
- Colorado Springs
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28