Hologic, Inc: 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 Comp

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.

Details from the source

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. Quantity: 1200 units Lot/code info: Model Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;

UPC codes

15420045514201

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.