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.