Back to RecallTracker
Health Canada Medical devices

ASPIRE Cristalle Mammography System

Issued July 3, 2025
Issue
FujiFilm became aware of an issue with the "maximum intensity projection ("MIP") service configuration setting, which setting may have been changed during installation from its default "no" setting to a "yes" setting. If this setting is in the "yes" position, it enables the slabbing function. This function is not approved for use in Canada. Recall start date: June 20, 2025
Hazard description
Unauthorised device
Product
Product name
ASPIRE Cristalle Mammography System
Reference
ID
RA-77666