Genius Digital Diagnostics System Review Station Display
Hologic is correcting Genius Review Station displays due to unauthorized configuration changes that deviate from validated settings.
Contact Hologic or your local representative to schedule a service visit to restore the display to the validated configuration and ensure future adherence to the Operator's Manual settings.
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.
How to identify it
UPC 15420045514201
Brand Name: Genius" Review Station
Where it was sold
Distributed in US.
Official source
Other recent recalls from Hologic, Inc
Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification