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3Dimensions

Hologic, Inc. · Model CLARITY HD SOFTWARE · UDI-DI 15420045507272

OTE Prescription

510(k) clearances

1,032

Adverse events (12 deaths)

Recalls

Facilities

Description

Hologic Clarity HD® (high resolution tomosynthesis) is a software driven digital breast tomosynthesis 3(D) imaging feature intended to improve image resolution on tomosynhesis slices and synthesized 2D images that will enhance image quality and user experience.

Recalls

Date	Firm	Reason
2026-04-08	Hologic, Inc	Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
2025-06-11	FUJIFILM Healthcare Americas Corporation	Devices had an unapproved slabbing software function enabled for use.
2024-08-19	Hologic Inc	Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synt
2023-01-16	Hologic, Inc.	C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
2016-02-12	Siemens Medical Solutions USA, Inc	A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast thickness larger tha

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.