Recall Z-2219-2025— FUJIFILM Healthcare Americas Corporation
Class II · Ongoing
Class II FDA medical device recall by FUJIFILM Healthcare Americas Corporation, initiated 2025-06-11. FDA's recall record names no specific 510(k) clearance for this event. Product: ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).. Reason: Devices had an unapproved slabbing software function enabled for use..
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-11
- Firm location
- Lexington, MA, United States
Product description
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Reason for recall
Devices had an unapproved slabbing software function enabled for use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.