Hologic, Inc recalls Brand Name: Genius" Review Station Product Name: Genius" Review Station Display

Recalling company

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 – may cause temporary or medically reversible health consequences

Recall date

Mar 23, 2026

Reported

May 6, 2026

Distribution

Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.

Status

Ongoing

Quantity

1200 units

Lot / codes

Model Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;

Company location

Marlborough, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-1949-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1949-2026 in the FDA Enforcement Report. Also see FDA recall press releases.