Selenia Dimensions Mammography Systems
Hologic recalls 20+ Selenia Dimensions mammography systems over loose or broken internal bolts.
Contact Hologic for inspection and repair of the affected mammography system. Do not use the system until it has been serviced.
Why it was recalled
Hologic is recalling 20+ variants of Selenia Dimensions mammography systems due to complaints of loose, missing, or broken internal bolts over time. The full list of affected model numbers is available on the FDA recall page.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. 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, SDM-SYS-9000-3D. | 15420045510616, 15420045517783, 15420045510753, 15420045510760, 15420045510623, 15420045510630, 15420045510647, 15420045510654, 15420045510661, 15420045510678, 15420045510685, 15420045510692, 15420045510708, 15420045510715, 15420045510722, 15420045510739, 15420045510746, 15420045510777, 15420045510784 | Z-2167-2026 |
| 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. | 15420045510609, 15420045510593, 15420045510586, 15420045510579, 15420045510562, 15420045510555, 15420045510524, 15420045510531, 15420045510548 | Z-2168-2026 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Hologic, Inc
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification