BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to th
Summary
The FDA issued a Class II for BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual by RONAN MEDICAL LLC. Reason: Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended..
Details
Source
Device Recall
External ID
Z-2737-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 12
Reason for Recall
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Distribution
Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-11
Company
Colorado Springs, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 409 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (RONAN MEDICAL LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RONAN MEDICAL LLC have FDA actions?
This is the only FDA action we have on record for RONAN MEDICAL LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2737-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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