Official recall notice
FDA Recall: Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Mo
- Recall date
- 2026-05-06
- Brand
- Hologic, Inc
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
1200 units
Product description
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.