Hologic, Inc recalls SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS.

Recalling company

Hologic, Inc

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.

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

4,305 units

Lot / codes

"Model No.; UDI": [SDA-SYS-3000-2D-HTC;15420045510616], [SDA-SYS-3000-3D;15420045517783], [SDM-SYS-6000-2D;15420045510753], [SDM-SYS-6000-3D;15420045510760], [SDM-00001-2D;15420045510623], [SDM-00001-3D;15420045510630], [SDM-00001-M2D;15420045510647], [SDM-00001-M3D;15420045510654], [SDM-05000-2A2;15420045510661], [SDM-05000-2A3;15420045510678], [SDM-05000-2AC;15420045510685], [SDM-05000-2D2;15420045510692], [SDM-05000-2D3;15420045510708], [SDM-05000-2DC;15420045510715], [SDM-05000-3D2;15420045510722], [SDM-05000-3D3;15420045510739], [SDM-05000-3DC;15420045510746], [SDM-SYS-9000-2D;15420045510777], [SDM-SYS-9000-3D;15420045510784]; All Serial No.

Company location

Marlborough, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-2167-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2167-2026 in the FDA Enforcement Report. Also see FDA recall press releases.