Reported May 20, 2026 · Ongoing
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D,…
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc · 250 Campus Dr · Marlborough, MA · 01752-3020
Is this the product you have?
- SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS
- Model Numbers
SDA-SYS-3000-2D-HTCSDA-SYS-3000-3DSDM-SYS-6000-2DSDM-SYS-6000-3DSDM-00001-2DSDM-00001-3DSDM-00001-M2DSDM-00001-M3DSDM-05000-2A2SDM-05000-2A3SDM-05000-2ACSDM-05000-2D2SDM-05000-2D3SDM-05000-2DCSDM-05000-3D2SDM-05000-3D3SDM-05000-3DCSDM-SYS-9000-2DSDM-SYS-9000-3D
- Lot codes and dates
"Model NoUDI": [SDA-SYS-3000-2D-HTC15420045510616][SDA-SYS-3000-3D15420045517783][SDM-SYS-6000-2D15420045510753][SDM-SYS-6000-3D15420045510760][SDM-00001-2D15420045510623][SDM-00001-3D15420045510630][SDM-00001-M2D15420045510647][SDM-00001-M3D15420045510654][SDM-05000-2A215420045510661][SDM-05000-2A315420045510678][SDM-05000-2AC15420045510685][SDM-05000-2D215420045510692][SDM-05000-2D315420045510708][SDM-05000-2DC15420045510715][SDM-05000-3D215420045510722][SDM-05000-3D315420045510739][SDM-05000-3DC15420045510746][SDM-SYS-9000-2D15420045510777][SDM-SYS-9000-3D15420045510784]All Serial No
- Amount recalled
- 4,305 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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