ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Reported: August 6, 2025 Initiated: June 11, 2025 #Z-2219-2025
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.
Details
- Recalling Firm
- FUJIFILM Healthcare Americas Corporation
- Units Affected
- 293 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.
- Location
- Lexington, MA
Frequently Asked Questions
What product was recalled? ▼
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).. Recalled by FUJIFILM Healthcare Americas Corporation. Units affected: 293 units.
Why was this product recalled? ▼
Devices had an unapproved slabbing software function enabled for use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 6, 2025. Severity: Moderate. Recall number: Z-2219-2025.
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