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Open, Classified

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.

FDA Recall Z-2737-2024 · Posted 2024-08-27

Recalling FirmRONAN MEDICAL LLC
Recall StatusOpen, Classified
Product CodeHCC
Date Initiated2023-12-11
Product Quantity12

Reason for Recall

Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.

Firm Action

Starting on 12/11/23, the firm telephoned customers and informed them that affected devices were being withdrawn and replaced.

Root Cause

Device Design

Distribution Pattern

Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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