Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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 physiological parameters.

U.S. FDA — Device Enforcement · United States · 2023-12-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2737-2024
Date of alert
2023-12-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
RONAN MEDICAL LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
08592566001017
Reported risk: Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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