ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FDA Recall Z-2219-2025 · Posted 2025-07-30
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Recalling FirmFUJIFILM Healthcare Americas Corporation
Recall StatusOpen, Classified
Product CodeOTE
Date Initiated2025-06-11
Product Quantity293 units
Reason for Recall
Devices had an unapproved slabbing software function enabled for use.
Firm Action
An URGENT: MEDICAL DEVICE RECALL FIRST NOTICE, dated 6/10/25, was sent to consignees. Consignees are to post the notification on/near affected devices and return the completed response form to coordinate a field service engineer to visit. Fujifilm will be sending a Fujifilm healthcare engineer to inspect affected systems and correct the settings to ensure the slabbing feature is inactive. Customers with any questions can contact Fujifilm Customer Service at 1-888-385-4633 or Fujifilm's Field Action Coordinator, Jay Wigley, at [email protected]. Functional/upgrade questions can be directed to the Technical Assistance Center at 1-888-385-4622.
Root Cause
Process control
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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