Hologic, Inc recalls 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3…

Recall date

April 8, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2168-2026

FDA classification

Class II

Brand / firm

Hologic, Inc

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.