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Selenia Dimensions C-View Software
Hologic, Inc. · Model C-View · UDI-DI 15420045500020
OTE
Prescription
0
510(k) clearances
975
Adverse events (12 deaths)
5
Recalls
23
Facilities
Description
Selenia® Dimensions® C-View Software is a software feature where a standard digital mammography image is generated from data acquired during a standard resolution breast tomosynthesis scan.
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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