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.
Devices had an unapproved slabbing software function enabled for use.
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.
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.
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.
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.
Review the model number and UDI codes listed in the recall notice to determine if your system is affected.
The official recall notice does not provide a remedy or fix for this issue.
Check if your system has model number CLLE-0229 or UDI codes listed in the recall notice.
The recall states there is an unapproved software function, but no specific injuries have been reported. The risk is related to incorrect imaging results, not direct injury.
We’ve drafted a message you can send FUJIFILM Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2219-2025 — FUJIFILM Healthcare FUJIFILM Healthcare Hello, I own a FUJIFILM Healthcare that is covered by recall Z-2219-2025 from FUJIFILM Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
