Hologic, Inc — Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 23, 2026
Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.
What's affected?
- Product
- Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.
- Brand
- Hologic, Inc
- Lot code
- Model Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;
Additional details
Model Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1200 units.
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