Class II

Medical Device Recall: ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

FUJIFILM Healthcare Americas Corporation · June 11, 2025

Reason for Recall

Devices had an unapproved slabbing software function enabled for use.

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

293 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2219-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

FUJIFILM Healthcare Americas Corporation Medical Device Recall: ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031). | SafeCheck