FDA DeviceClass IINotable

FDA Recall: 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS

Date: 2026-05-20
Brand: Hologic, Inc
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

14837 units

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