Class IIOngoingZ-2168-2026
Hologic, Inc recalls 3DIMENSIONS MAMMOGRAPHY SYSTEM
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Hologic, IncMAMay 20, 2026
Digital Breast Tomosynthesis recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–2 of 2 recalls
Class IIOngoingZ-2219-2025
FUJIFILM Healthcare Americas Corporation recalls ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE…
Devices had an unapproved slabbing software function enabled for use.
FUJIFILM Healthcare Am…MAAug 6, 2025