Company: FUJIFILM Healthcare Americas Corporation
Date of Enforcement Report: 7/30/2025
Class: II
PRODUCT
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031)
Recall Number:
Z-2219-2025
REASON:
Devices had an unapproved slabbing software function enabled for use.
RECALLING FIRM/MANUFACTURER:
FUJIFILM Healthcare Americas Corporation
VOLUME:
293 units
DISTRIBUTION:
Worldwide distribution – US Nationwide and the countries of Canada, Chile, Ecuador.
