Device 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.
Z-1949-2026
Product summary
- Firm
- Hologic, Inc
- Event
- Event 98487
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1200 units
- Official record key
device-enforcement:Z-1949-2026
Official wording
Reason: 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.
Code information: Model Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.
Derived failure modes
-
Unknown
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.