Ronan Medical recalls BrainFeedback Pro 2 devices due to missing design documentation, which could cause them to not function as intended. Affected units have specific serial numbers and UDI-DI codes.
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Ronan Medical is recalling BrainFeedback Pro 2 devices because they lack proper design and development documentation. This means the devices might not work correctly as intended, potentially affecting patient safety.
The devices were built without complete design and development documentation. This could lead to them not performing as intended, which might impact patient safety during neurofeedback sessions.
Patients using the BrainFeedback Pro 2 device for neurofeedback training are likely affected. Those with the specific serial numbers or UDI-DI codes listed are most at risk.
Check for the serial numbers ACBFB12-1911003 through ACBFB12-2301024 or UDI-DI codes 08592566001017 and 08592566001123 on the device packaging or label.
Look for the serial numbers ACBFB12-1911003 through ACBFB12-2301024 or UDI-DI codes 08592566001017 and 08592566001123 on the device packaging or label.
The BrainFeedback Pro 2 devices lack complete design and development documentation, which could cause them to not function as intended.
Check the device for the specific serial numbers or UDI-DI codes listed in the recall notice. If you have one, contact Ronan Medical for further instructions.
The devices may not perform as intended due to missing documentation, which could affect patient safety during neurofeedback sessions.
We’ve drafted a message you can send Ronan Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2737-2024 — Ronan Medical Ronan Medical Hello, I own a Ronan Medical that is covered by recall Z-2737-2024 from Ronan Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
