ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynt

FDA device recall Z-2219-2025 · posted 2025-07-30 · Open, Classified

Recall details

Recalling firm

FUJIFILM Healthcare Americas Corporation

Reason for recall

Devices had an unapproved slabbing software function enabled for use.

Action taken

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 directed to the Technical Assistance Center at 1-888-385-4622.

Root cause

Process control

Status

Open, Classified

Product code

OTE

Quantity affected

293 units

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.

Date initiated

2025-06-11

Date posted

2025-07-30

Location

Lexington, MA