FDA Recall: Devices had an unapproved slabbing software function enabled for use

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:

REASON:

Devices had an unapproved slabbing software function enabled for use.

RECALLING FIRM/MANUFACTURER:

FUJIFILM Healthcare Americas Corporation

VOLUME:

DISTRIBUTION:

Worldwide distribution – US Nationwide and the countries of Canada, Chile, Ecuador.