Official recall notice

FDA DeviceClass IINotable

Selenia Dimensions Mammography Systems Recall (May 2026)

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.

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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