Use cautionMedical device recall · FDA · Published March 23, 2026
Hologic Genius Review Station Display Recall: User Modifications Risk Safety
Hologic recalls Genius Review Station Display (model CMP-016:01669) due to user modifications causing safety risks. Affected users should stop using modified devices until corrected.
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.
Take action
Contact the company
📍Recalling firmHologic, Inc250 Campus Dr · Marlborough, MA 01752-3020
“Hologic Genius Review Station Display Recall: User Modifications Risk Safety.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49645-hologic-genius-review-station-display-recall-user-modifications-risk-safety. Based on FDA recall #Z-1949-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1949-2026%22&limit=1).
Hologic, Inc., with FDA assistance, is recalling Genius Review Station Displays (Barco Monitor) model CMP-01669 due to user-modified settings that operate devices outside validated configurations, the agency announced on March 23, 2026. The recall affects 1,200 units distributed worldwide.
How to tell if you have it
Brand: Hologic
Product Name: Genius Review Station Display (Barco Monitor)
Model/Catalog Number: CMP-01669
Quantity: 1,200 units
The hazard
The FDA stated that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of manufacturer-installed settings. These modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings.
Context
GovInfoNow's records show Hologic, Inc has 30 other recalls on record since June 27, 2017. Other recent recalls of similar products include Philips Brilliance CT 64 Medical Scanner Recall (August 7, 2026), Philips Azurion 5 M12 System Software Recalls (January 26, 2026) and Philips Azurion 7 B20 System Recall (January 26, 2026).
How to tell if you have this one
Check for the model number CMP-01669 on the device. The recall affects all units sold with this model number, regardless of software version.
Brand
Hologic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Settings
Verify if the Barco Application Appearance Manager (AAM) is enabled and calibration settings are correct.
Contact Manufacturer
Reach out to Hologic for guidance on restoring the device to the validated configuration.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1949-2026 (March 23, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1949-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.