CLASS II ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report
BrainFeedback Pro 2 Device - is intended as an instrument recalled
Ronan Medical is recalling BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and, distributed nationwide in the US. The recall was initiated on 11 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2737-2024
- FDA event ID
- 95089
- Recalling firm
- Ronan Medical, Colorado Springs, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Dec 2023
- FDA classified
- 27 Aug 2024
- Reported
- 4 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 11 Dec 2023 | Recall initiated by company | |
| 27 Aug 2024 | Classified by FDA | +260 days |
| 4 Sep 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
Nationwide CaliforniaConnecticutFloridaIllinoisMichiganTennessee
Questions about this recall
Is BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and recalled?
Yes. Ronan Medical recalled BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and on 11 Dec 2023. The recall is Class II and its status is Ongoing. Recall number Z-2737-2024.
Why was it recalled?
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Which lots are affected?
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
Where was it sold?
Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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