FDA recall, , Moderate risk
Genius Review Station Display (Barco Monitor)
The Genius Review Station Display can be operated outside its validated configuration due to user modifications.
Summary by Recall Canary from the FDA notice
What happened
Hologic, Inc., of Marlborough, Massachusetts, began a recall on March 23, 2026, of the Genius" Review Station Display (Barco Monitor), model CMP-01669, a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm. The recall was added to the FDA's Enforcement Report and classified on April 24, 2026, and appeared in the FDA's weekly enforcement report on May 6, 2026.
The recall was initiated because certain devices were operated outside the validated and FDA-cleared display configuration due to user modification of manufacturer-installed settings, including disabling Barco Application Appearance Manager, altering calibration and compliance parameters, and adjusting additional display-related settings.
The affected devices were distributed worldwide, including US Nationwide and countries in Asia Pacific, Europe, and the Middle East.
What to do
If a code on your device is listed below:
- 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.
Is yours affected?
Affected if its model number matches.
Genius Review Station Display (Barco Monitor)
- Model number
- CMP-01669
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.
- Company
- Hologic, IncMarlborough, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98487
- Recall number
- Z-1949-2026
- Quantity recalled
- 1200 units
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
