Hologic Genius Review Station Display Recall
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Ver
Updated March 23, 2026
Some Hologic Genius Review Station Display monitors (model CMP-01669) were modified away from their FDA-approved settings, which could affect their ability to display medical images correctly. Hologic is correcting affected devices to restore proper operation.
Is the Hologic, Inc recalled? Yes. This product was recalled by FDA on March 23, 2026. Details below.
What is recalled
Hologic Genius Review Station Display (Barco Monitor), model CMP-01669, used as part of the Genius Digital Diagnostics System with the Genius Cervical AI Algorithm.
Am I affected
You're affected if your facility operates a Genius Review Station Display (Barco Monitor) model CMP-01669 and settings such as the Barco Application Appearance Manager (AAM) have been disabled or calibration and compliance parameters have been altered from manufacturer defaults.
What to do right now
Contact Hologic, Inc. to have your Genius Review Station Display restored to its validated factory configuration and to receive guidance on proper use per the Operator's Manual.
The hazard
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.
Brands affected
- Source
- FDA
- Category
- Baby & Kids
- Recall ID
- fda-Z-1949-2026
- Classification
- Class II
- Recalled
- March 23, 2026
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