Hologic, Inc: 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.

Recall number

Z-1949-2026

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.

Status

Open, Classified

Initiated

2026-03-23

Posted

2026-04-24

Terminated

not on file

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.

Root cause

Software design

Action

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.

Quantity

1200 units

Distribution

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

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

QYV

Firm FEI

1000120743

Firm city

Marlborough

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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