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.
Enforcement
- Recall Number
- Z-1949-2026
- Event ID
- 98487
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Hologic, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 6, 2026
- Initiation Date
- March 23, 2026
- Classification Date
- April 24, 2026
- Address
- 250 Campus Dr, Marlborough, MA, 01752-3020, United States
Description
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.
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.
Model Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;
Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.
1200 units