{"url_path":"/fda/device/recalls/Z-1949-2026","section_key":"summary","section_title":"DEVICE Recall: 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.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-23","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1949-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Hologic, Inc"},"word_count":170,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-1949-2026\n\n**Recalling firm:** Hologic, Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-23\n**Report date:** 2026-05-06\n\n## Product\nBrand 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.\n\n## Reason\nIt 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.\n\n## Affected lots\nModel Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;\n\n## Distribution\nWorldwide distribution - US Nationwide  and the countries of Asia Pacific, Europe, and the Middle East."}