Recall Z-1949-2026 ยท QYV Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
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 Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.
| Date | Apr 24, 2026 (initiated Mar 23, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | On March 23, 2026, Urgent Medical Device Recall letters were sent to customers. Actions to be taken: If you are receiving this notification, our records indicate that you have received a Genius" Review Station Monitor (CMP-01669). As this field correction applies to all monitors, please follow the instructions below and complete the Customer Response Form (CRF) using the link or QR code provided below. If you are a distributor or otherwise supply Genius" Review Station Monitors to downstream customers, you are responsible for promptly forwarding this notification to all affected sub-accounts a |
| Quantity | 1200 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.