Brand Name: Genius" Review Station Product Name recall
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A…
Why was Brand Name: Genius" Review Station Product Name recalled?
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;
- Product
- Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A…
- Recalling firm
- Hologic, Inc
- Quantity
- 1200 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.
- Recall date
- May 6, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)