Reported May 6, 2026 · Ongoing
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number:…
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc · 250 Campus Dr · Marlborough, MA · 01752-3020
Is this the product you have?
- Brand NameGenius"
- Review Station Product NameGenius" Review Station Display (Barco
- Monitor) Model/Catalog NumberCMP-01669
- Software VersionN/A -
- not software version specific ComponentYes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035
- Lot codes and dates
- Model NumberCMP-01669
- UDI-DI15420045514201
- Serial NumberAll
- Amount recalled
- 1200 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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