Recall Z-1949-2026— Hologic, Inc

Class II FDA medical device recall by Hologic, Inc, initiated 2026-03-23. FDA's recall record names no specific 510(k) clearance for this event. 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 System with the Genius" Cervical AI Algorithm cleared under DEN210035.. Reason: 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..

Recalling firm

Hologic, Inc

Classification

Class II

Status

Ongoing

Initiated

2026-03-23

Firm location

Marlborough, MA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.