Genius Digital Diagnostics System Review Station Display
Hologic is recalling Genius Review Station displays (Model CMP-01669) due to unauthorized user modifications to validated monitor settings.
Contact Hologic or your local representative to schedule a field correction to restore the display to its validated configuration and ensure compliance with the Operator's Manual.
Recall at a glance
- Quantity recalled
- 1200 units
Why it was recalled
Hologic is recalling the Genius Review Station Display (Barco Monitor) because certain units were operated outside of validated and FDA-cleared configurations. Users modified manufacturer-installed settings, including disabling the Barco Application Appearance Manager, which could impact the display's performance. The recall is distributed nationwide.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Genius" Review Station Display (Barco Monitor)
- UDI-DI
- 15420045514201
- 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
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Hologic, Inc
Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification