ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Recall
- Recall Number
- Z-2219-2025
- Event Number
- 97063
- Firm
- FUJIFILM Healthcare Americas Corporation
- FEI Number
- 1000513161
- Product Code
- OTE
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- June 11, 2025
- Posted
- July 30, 2025
- Address
- 81 Hartwell Ave, Ste 300, Lexington, MA, 02421-3160
Description
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Devices had an unapproved slabbing software function enabled for use.
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.
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.
293 units