# FDA recall Z-1949-2026

> **Hologic, Inc** · Class II · device recall initiated 2026-03-23.

## 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.

## Distribution

Worldwide distribution - US Nationwide  and the countries of Asia Pacific, Europe, and the Middle East.

## Key facts

- **Recall number:** Z-1949-2026
- **Recalling firm:** Hologic, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-23
- **Report date:** 2026-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1949-2026

## Citation

> AI Analytics. FDA recall Z-1949-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1949-2026. Source: US FDA. Licensed CC0.

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