Recall Z-2219-2025 ยท OTE Digital Breast Tomosynthesis
FUJIFILM Healthcare Americas Corporation
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
| Date | Jul 30, 2025 (initiated Jun 11, 2025) |
| Status | Open, Classified |
| Reason | Devices had an unapproved slabbing software function enabled for use. |
| Root cause | Process control |
| 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 hcusquality@fujifilm.com. Functional/upgrade questions can be direct |
| Quantity | 293 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.