Hologic recalls SELENIA Dimensions Mammography Systems with model numbers SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, and others due to loose, missing, or broken internal bolts that could affect system stability.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Hologic is recalling several models of SELENIA Dimensions Mammography Systems because internal bolts can become loose, missing, or broken over time. This could potentially cause the system to become unstable during use, which may lead to injury or equipment damage.
Internal bolts in the mammography systems can become loose, missing, or broken over time. This could cause the system to become unstable during use, potentially leading to injury or equipment damage if not addressed.
Healthcare facilities and medical professionals who use these mammography systems are most at risk. The recall affects specific model numbers sold for medical imaging.
Check the model numbers on the system: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, and other listed models. The recall includes all units with the specified model numbers and serial numbers.
Identify the model number on your SELENIA Dimensions Mammography System to see if it matches the recalled list.
Reach out to Hologic for guidance on next steps, as the recall does not include a specific remedy.
The recall affects SELENIA Dimensions Mammography Systems with model numbers SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, and SDM-SYS-9000-3D.
Complaints have been received that internal bolts in these systems can become loose, missing, or broken over time, which could affect system stability.
The recall does not include a specific remedy. Contact Hologic directly for guidance on next steps.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-2167-2026 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-2167-2026 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.
