United StatesThe Genius Review Station Display (Barco Monitor), model CMP-01669 (UDI-DI 15420045514201), used as a component of the Genius Digital Diagnostics System, is affected. Certain units were operated outside the validated and FDA-cleared display configuration after users modified manufacturer-installed settings (including disabling Barco Application Appearance Manager, altering calibration and compliance parameters, and other display settings). Hologic is conducting a field correction to restore affected systems to the validated configuration and to reinforce proper use per the Operator's Manual.
What's being recalled
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.
Recalling firm: Hologic, Inc, Marlborough, MA, United States.
How to identify it
Model Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)