Recall
FDAHealthMarch 23, 2026

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.
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.

View original FDA notice →

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