Official recall notice

FDA DeviceClass IINotable

Mammography System Recall (May 2026) – Hologic

Product: 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.

Recall date
2026-05-20
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Verify with the official notice →
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