Hologic, Inc Recall: Brand Name: Genius" Review Station Product Name: Genius" Review Stati
Hologic, Inc Recall: Brand Name: Genius" Review Station Product Name: Genius" Review Stati is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Hologic, Inc; Product: Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01
| Recalling firm | Hologic, Inc |
|---|---|
| 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 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East. |
| Recall initiated | 20260323 |
| Recall number | Z-1949-2026 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
Try RecallGuard →