Official recall record
ASPIRE Cristalle Mammography System
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-07-03
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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