FUJIFILM ASPRIRE Cristalle Mammography System Recall: Unapproved Software Function
FUJIFILM Healthcare recalls ASPRIRE Cristalle Mammography Systems with unapproved slabbing software. Affected units have specific model numbers and UDI codes. No remedy provided in official notice.
Lower-risk recall
Devices had an unapproved slabbing software function enabled for use.
Contact the company
What happened, in plain English
FUJIFILM Healthcare is recalling ASPRIRE Cristalle Mammography Systems installed with the ASPIRE Cristalle Digital Breast Tomosynthesis option due to an unapproved software function. This could pose a risk if the software is used incorrectly, but no specific injuries have been reported. Read more at govinfonow.com/recall/52074-fujifilm-asprire-cristalle-mammography-system-recall-unapproved-software-function.
Source Summary by GovInfoNow · govinfonow.com/recall/52074-fujifilm-asprire-cristalle-mammography-system-recall-unapproved-software-function · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2219-2025
Cite this page
“FUJIFILM ASPRIRE Cristalle Mammography System Recall: Unapproved Software Function.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52074-fujifilm-asprire-cristalle-mammography-system-recall-unapproved-software-function. Based on FDA recall #Z-2219-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2219-2025%22&limit=1).
Why it’s dangerous
The system has an unapproved software function that could be activated during use. This function may cause incorrect imaging results if not properly managed, but it does not pose a direct risk of injury or damage to the user.
Who’s affected
Healthcare facilities that installed the ASPRIRE Cristalle Mammography System with the ASPIRE Cristalle Digital Breast Tomosynthesis option. Medical staff and patients using these systems may be at risk if the unapproved software function is activated.
How to tell if you have this one
Check for model number CLLE-0229 or UDI codes listed in the recall notice. The affected systems were installed with the ASPIRE Cristalle Digital Breast Tomosynthesis option and cleared under K212873.
- Brand
FUJIFILM Healthcare- Product
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast- Category
Medical device
What to do — step by step
Check Product Details
Review the model number and UDI codes listed in the recall notice to determine if your system is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2219-2025 (June 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2219-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.