Hologic, Inc — Class II: Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Mo
Hologic, Inc initiated a Class II field correction for certain Genius Review Station displays due to user modifications that moved the devices outside of their validated and FDA-cleared configurations. Specifically, users disabled the Barco Application Appearance Manager and altered calibration, compliance, and other display parameters.
This affects Hologic, Inc, users of the Genius Digital Diagnostics System and Genius Cervical AI Algorithm, and healthcare facilities utilizing the Genius Review Station for diagnostic review.
This action highlights the regulatory risks associated with end-user modification of manufacturer settings on cleared medical devices. When a system is operated outside of its validated configuration—particularly for diagnostic displays—the performance and reliability of the cleared algorithm or diagnostic output may be compromised. Regulatory departments should view this as a reminder that field corrections may be necessary to restore devices to their cleared state, even if the deviation was caused by the customer rather than a manufacturing defect.
Verify that field units remain in validated configurations and consider implementing technical controls or 'lock-outs' to prevent unauthorized modification of critical display or performance settings by end-users. Regulatory teams should ensure that Operator's Manuals explicitly define the boundaries of validated configurations for integrated components.
Class II. 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.. 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.. Firm: Hologic, Inc (Marlborough MA United States). Status: Ongoing.
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