Hologic, Inc — Class II recall: Brand Name: Genius" Review Station Product Name: Genius" Review Station Display…

Summary

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 par… Status: Ongoing.

Entities

• Hologic, Inc