Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Selenia Full Field Digital Mammography System with software versions 5.0.x Recalled by Hologic, Inc. Due to Software: When the Selenia upon meeting the hard...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hologic, Inc. directly.
Affected Products
Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography
Quantity: 62 systems
Why Was This Recalled?
Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
Where Was This Sold?
This product was distributed to 19 states: AL, AR, CA, CO, FL, IL, KY, LA, NE, NJ, NY, NC, OH, PA, TN, TX, UT, WA, WV
About Hologic, Inc.
Hologic, Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report