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GENIUS AI DETECTION

Hologic, Inc. · Model GENIUS AI DETECTION SOFTWARE · UDI-DI 15420045512474

OTE Prescription

510(k) clearances

1,001

Adverse events (12 deaths)

Recalls

Facilities

Description

Genius AI® is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthsis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions, and assymetries) and calcifications in DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score.

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.