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July 30, 2025
30
Jul

FDA Recall: Devices had an unapproved slabbing software function enabled for use

July 30, 2025
Company: FUJIFILM Healthcare Americas Corporation Date of Enforcement Report: 7/30/2025 Class: II PRODUCT ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031) Recall Number: Z-2219-2025 REASON: Devices had an unapproved slabbing software function enabled for use. RECALLING FIRM/MANUFACTURER: FUJIFILM Healthcare Americas Corporation VOLUME: 293...
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