FDA DeviceClass IINotable

FDA Recall: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS

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

4,305 units

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