Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number:
Summary
The FDA issued a Class II for Brand Name: Genius" Review Station Product Name: Genius" Review Station Display by Hologic, Inc. Reason: It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the.
Details
Source
Device Recall
External ID
Z-1949-2026
Action Date
2026-05-06
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Model Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;
Quantity Affected: 1200 units
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-23
Company
Marlborough, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 275 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hologic, Inc has 41 FDA actions in our database, including 22 recalls and 19 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hologic, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hologic, Inc have FDA actions?
Hologic, Inc has 41 FDA actions in our database, including 22 recalls and 19 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1949-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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