RONAN MEDICAL LLC: Medical Device Recall in 2024 - (Recall #: Z-2737-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 11, 2023

Date Posted: September 4, 2024

Recall Number: Z-2737-2024

Event ID: 95089

Reason for Recall:

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

Status: Ongoing

Product Quantity: 12

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated