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FUJIFILM Healthcare Americas Corporation recalls ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynt
Recalled August 6, 2025 · FDA recall Z-2219-2025 · FUJIFILM Healthcare Americas
Hazard
Devices had an unapproved slabbing software function enabled for use. · FDA Class II
Units
293 units
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.
Description
Devices had an unapproved slabbing software function enabled for use.
Product
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Manufacturer(s)
FUJIFILM Healthcare Americas Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →