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.
Published May 6, 2026 · Recall initiated: March 23, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hologic, Inc
- Distributor
- Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.
- Lot
- Model Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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