Hologic, Inc recalls SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-60

Recalled May 20, 2026 · FDA recall Z-2167-2026 · Hologic

Hazard

Complaints have been received of systems developing loose, missing, or broken internal bolts over time. · FDA Class II

Units

4,305 units

Sold at

US Nationwide distribution.

Description

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

Product

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.

Manufacturer(s)

Hologic, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →