FUJIFILM Healthcare Americas Corporation recalls ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosyn…
- Recall date
- June 11, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2219-2025
- FDA classification
- Class II
- Brand / firm
- FUJIFILM Healthcare Americas Corporation
- Sold / distributed
- Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.
Why it was recalled
Devices had an unapproved slabbing software function enabled for use.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
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