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Envision
Hologic, Inc. · Model ASY-15787 · UDI-DI 15420045516366
OTE
Prescription
0
510(k) clearances
975
Adverse events (12 deaths)
5
Recalls
23
Facilities
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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Get your free API keyRead the docsData 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.