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Hologic, Inc 2026-05-06 Health serious FDA
Health · FDA · Recall #FDA-Z-1949-2026

Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco… Recall

Issued May 6, 2026 · Hologic, Inc

In May 2026, Hologic, Inc recalled the Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco…, a serious health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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.

What you should do

  1. 1 Stop using Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Hologic, Inc to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Hologic, Inc
Category
Health
Recall date
May 6, 2026
Units affected
Not reported
Sold at
Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.
Recall number
FDA-Z-1949-2026
Made in
United States
Issuing agency
FDA

In context

  • Hologic, Inc has 4 recalls in our database, including 1 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 356th Health recall we've logged in 2026.
Read the official FDA notice

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