Use cautionMedical device recall · FDA · Published August 19, 2024
Hologic Selenia Software Versions 1.12.0 and 2.3.0 May Cause Blurry Images Leading
Hologic recalls specific software versions for breast tomosynthesis systems that may produce blurry images when used with C-View software, potentially causing false negative diagnoses. Affected users should contact Hologic for updates.
Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis
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Contact the company
📍Recalling firmHologic Inc600 Technology Dr · Newark, DE 19702-2463
✎ GovInfoNow plain-language explainer
Hologic is recalling software versions 1.12.0 and 2.3.0 for their Selenia breast tomosynthesis systems. These versions may create blurry images when used with C-View software, which could lead to missed diagnoses. This is serious because false negatives in medical imaging can have serious health consequences. Read more at govinfonow.com/recall/54210-hologic-selenia-software-versions-1-12-0-and-2-3.
“Hologic Selenia Software Versions 1.12.0 and 2.3.0 May Cause Blurry Images Leading.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54210-hologic-selenia-software-versions-1-12-0-and-2-3. Based on FDA recall #Z-3248-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3248-2024%22&limit=1).
The FDA announced on Aug. 19, 2024, that Hologic Inc is recalling Selenia Dimensions and 3Dimensions digital breast tomosynthesis software versions 1.12.0 and 2.3.0 due to a hazard of blurry images that may lead to false negative diagnoses. The recall affects 425 units distributed worldwide, including in the U.S., Belgium, Canada, Israel, Korea, and the Netherlands.
How to tell if you have it
Brand: Hologic
Product: Selenia Dimensions/3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0
The software, when used with C-View software, may produce final synthesized 2D images that appear blurry. This issue can result in misdiagnosis, specifically the possibility of a false negative diagnosis.
Context
GovInfoNow's records show Hologic, Inc has 30 other recalls on record since 2017-06-27. Other recent recalls include the Hologic 3D Mammography Systems Recall for loose bolts risk (2026-04-08), the Hologic Genius Review Station Display Recall for user modifications risk safety (2026-03-23), and the Hologic Aptima HPV Assay Kit Recall for false negative results risk (2026-02-18).
How to tell if you have this one
Check if your Selenia Dimensions software is version 1.12.0 or 3Dimensions software is version 2.3.0. The affected software is used with C-View software for breast imaging. The recall includes specific upgrade kits and software versions listed in the product details.
Brand
Hologic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Identify your Selenia Dimensions software version or 3Dimensions software version to see if it is 1.12.0 or 2.3.0.
Contact Hologic
Reach out to Hologic for instructions on updating to a corrected software version or other remedies.
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 Belgium, Canada, Israel, Korea, Republic of, Netherlands.” 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 recall states there is a risk of misdiagnosis due to blurry images, but no direct injury risk is mentioned. The primary concern is potential false negatives in medical imaging.
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-3248-2024 (August 19, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3248-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.