Reported May 20, 2026 · Ongoing
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D,…
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?
- 3DIMENSIONS MAMMOGRAPHY SYSTEM
- Model Numbers
3DM-SYS-INTL2D3DM-SYS-INTL2D-MOB3DM-SYS-INTL2D-NS3DM-SYS-INTL3D3DM-SYS-INTL3D-MOB3DM-SYS-INTL3D-NS3DM-SYS-STD3DM-SYS-STD-MOB3DM-SYS-STD-NS
- Lot codes and dates
"[Model NoUDI]: [3DM-SYS-INTL2D15420045510609][3DM-SYS-INTL2D-MOB15420045510593][3DM-SYS-INTL2D-NS15420045510586][3DM-SYS-INTL3D15420045510579][3DM-SYS-INTL3D-MOB15420045510562][3DM-SYS-INTL3D-NS15420045510555][3DM-SYS-STD15420045510524][3DM-SYS-STD-MOB15420045510531][3DM-SYS-STD-NS15420045510548]All Serial No
- Amount recalled
- 14837 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.
Want the full recall guide?
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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