Genius Review Station Display Modified Outside Validated Configuration
Hologic is correcting Genius Review Station displays (model CMP-01669) that were modified by users outside the FDA-cleared configuration. The devices need restoration to validated settings per the manufacturer's Operator's Manual.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is improper device configuration due to user modification, and the agency's response is a precautionary field correction to restore validated settings. No illness or injury has been reported.
Plain-English summary
Hologic, Inc. is conducting a field correction of its Genius Review Station Display (Barco Monitor, model CMP-01669). Certain devices have been operated outside the validated and FDA-cleared display configuration due to user modification of manufacturer-installed settings.
The modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. These changes caused the systems to depart from their cleared state.
This field correction restores affected systems to their validated configuration and reinforces proper use in accordance with the Operator's Manual. The Genius Review Station is a component of the Genius Digital Diagnostics System with the Genius Cervical AI Algorithm. Approximately 1,200 units have been distributed worldwide, including across the United States, Asia Pacific, Europe, and the Middle East.
The recalled product
- 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 S
- Manufacturer
- Hologic, Inc
- Hazard
- device-configuration-drift
- improper-use
- settings-modification
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: CMP-01669
- UDI-DI: 15420045514201
- Serial Number: All
Distribution
Distributed nationwide across the United States.
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