Hologic, Inc recalls 3DIMENSIONS MAMMOGRAPHY SYSTEM
- Recalling company
- Hologic, Inc
- Product
- 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.
- Reason
- Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 8, 2026
- Reported
- May 20, 2026
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 14837 units
- Lot / codes
- "[Model No.; UDI]: [3DM-SYS-INTL2D;15420045510609], [3DM-SYS-INTL2D-MOB;15420045510593], [3DM-SYS-INTL2D-NS;15420045510586], [3DM-SYS-INTL3D;15420045510579], [3DM-SYS-INTL3D-MOB;15420045510562], [3DM-SYS-INTL3D-NS;15420045510555], [3DM-SYS-STD;15420045510524], [3DM-SYS-STD-MOB;15420045510531], [3DM-SYS-STD-NS;15420045510548]; All Serial No.
- Company location
- Marlborough, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2168-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2168-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.