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Selenia Dimensions Mammography Systems
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MEDICAL DEVICE RECALLMODERATE

Selenia Dimensions Mammography Systems

Hologic recalls Selenia Dimensions mammography systems over loose or broken internal bolts.

What to do

Contact Hologic for instructions on inspection and repair of your system. Do not use the system until it has been serviced.

Recalled
Listed
Updated
Recall No.
Z-2167-2026
Agency
FDA
Firm
Hologic, Inc
Recall ID
98566
Status
ONGOING

Why it was recalled

Hologic is recalling Selenia Dimensions Mammography Systems due to complaints of loose, missing, or broken internal bolts over time, which may affect system performance. 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.

ProductRecall #UDI-DI
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.Z-2167-202615420045510616, 15420045517783, 15420045510753, 15420045510760, 15420045510623, 15420045510630, 15420045510647, 15420045510654, 15420045510661, 15420045510678, 15420045510685, 15420045510692, 15420045510708, 15420045510715, 15420045510722, 15420045510739, 15420045510746, 15420045510777, 15420045510784
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.Z-2168-202615420045510609, 15420045510593, 15420045510586, 15420045510579, 15420045510562, 15420045510555, 15420045510524, 15420045510531, 15420045510548

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other recent recalls from Hologic, Inc

All recalls from Hologic, Inc

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Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification