Brand Name: Genius" Review Station recallZ-1949-2026 · Hologic, Inc · initiated Mar 23, 2026

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

On March 23, 2026, Urgent Medical Device Recall letters were sent to customers. Actions to be taken: If you are receiving this notification, our records indicate that you have received a Genius" Review Station Monitor (CMP-01669). As this field correction applies to all monitors, please follow the instructions below and complete the Customer Response Form (CRF) using the link or QR code provided below. If you are a distributor or otherwise supply Genius" Review Station Monitors to downstream customers, you are responsible for promptly forwarding this notification to all affected sub-accounts and ensuring completion of the CRF for each end-user site. Do not change monitor settings " Continue to use the Genius" Review Station only with the original monitor settings configured by Hologic at installation. " Do not: " Disable Barco Application Appearance Manager (AAM) " Change Barco QAWeb calibration or compliance test settings " Adjust or otherwise modify the monitor configuration parameters outside of the original configuration by Hologic at installation. " Only Hologic, or its authorized provider may modify Genius" Review Station monitor configuration settings. If monitor settings have been altered " If you are aware that monitor display or calibration settings have been changed from the original configuration, do not use the Genius" Review Station monitor for clinical review until the monitor has been returned to the original configuration by Hologic or its authorized service provider. " Complete the Customer Response Form (CRF) so Hologic and its field service partner, IQVIA MedTech, can coordinate restoration of the approved configuration. Please promptly fill out the Customer Response Form (CRF) to acknowledge you have received this notification. Distributors should ensure that all downstream customers complete the CRF or provide the required information on their behalf.

Recall details

Recall number

Z-1949-2026

Status

Open, Classified

Initiated by the company

Mar 23, 2026

Posted by the FDA

Apr 24, 2026

Recalling firm

Hologic, Inc

Quantity

1200 units

Product code

QYV

Distribution

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

Product description

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• DIGITAL DIAGNOSTICS SYSTEM DISPLAY, 27IN, 8MP

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  1 recall0 reports