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
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.
The software versions 1.12.0 and 2.3.0 may produce blurry images when combined with C-View software. This could lead to misdiagnosis, specifically false negative results where a condition is not detected when it should be. False negatives in breast imaging can delay treatment and worsen health outcomes.
Medical professionals using Hologic Selenia breast tomosynthesis systems with the recalled software versions are most at risk. Patients receiving imaging with these systems could potentially miss critical health issues due to blurry images.
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.
Identify your Selenia Dimensions software version or 3Dimensions software version to see if it is 1.12.0 or 2.3.0.
Reach out to Hologic for instructions on updating to a corrected software version or other remedies.
This recall is important because the software versions may produce blurry images when used with C-View software, which could lead to missed diagnoses. False negatives in breast imaging can delay treatment and affect health outcomes.
Contact Hologic directly to determine if your software is affected and to get instructions for updating to a corrected version.
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.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-3248-2024 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-3248-2024 from Hologic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
