Hologic, Inc: Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

Recall Summary Hologic is recalling Genius Review Station display monitors (model CMP-01669) used in cervical cancer screening systems because some devices were modified by users to operate outside their FDA-approved settings, including disabling safety features and altering calibration parameters. The recall affects devices distributed nationwide in the US and internationally in Asia Pacific, Europe, and the Middle East. Hologic is conducting a field correction to restore these systems to their validated configuration and proper operating specifications.

Recalling firm: Hologic, Inc
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.
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.
Classification: Class II
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-03-23
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.

Recall details on Nibble Recalls: https://trynibble.app/recalls/c374ebe1-2028-40c6-92d3-1cfb7ad65203