Z-2737-2024Class II

BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal...

Name: Z-2737-2024 BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal...
Creator: Ronan Medical Llc
Published: 2023-12-11
License: https://open.fda.gov/license/

Ronan Medical LLC / initiated 2023-12-11 / Open, Classified / root cause: design

FDA source

RONAN MEDICAL LLC began a recall of BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological... on 2023-12-11. FDA classified it as Class II and gives the reason as "Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2737-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-11
Posted: 2024-08-27
Recalling firm: Ronan Medical LLC
Product: 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 code: HCC Device, Biofeedback
Reason for recall: Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Root cause tag: design
FDA root cause: Device Design
Action: Starting on 12/11/23, the firm telephoned customers and informed them that affected devices were being withdrawn and replaced.
Quantity in commerce: 12
Distribution: Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2737-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2737-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-27

Product code HCC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)