The Recall Desk
HighFDA (Devices)·Z-2219-2025·Announced 2025-08-06

FUJIFILM Mammography Systems Recalled for Unapproved Software Function

FUJIFILM is recalling 293 ASPRIRE Cristalle Mammography Systems worldwide due to an unapproved slabbing software function being enabled for use. Affected units were distributed in the United States, Canada, Chile, and Ecuador.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving an unapproved software function in a diagnostic imaging system. No illnesses, injuries, or reported patient harm have been documented, placing this in the risk-of-harm category without actual harm reported, which aligns with the High (3) classification per the rubric.

Plain-English summary

The ASPRIRE Cristalle Mammography System with the ASPRIRE Cristalle Digital Breast Tomosynthesis (DBT) Option, manufactured by FUJIFILM Healthcare Americas Corporation, is being recalled. The system is used for mammography and breast imaging in clinical settings. A total of 293 units worldwide are affected.

The recalled devices were distributed with an unapproved software slabbing function enabled for use. This software function was not part of the device's approved regulatory clearance and should not have been active on systems shipped to healthcare facilities.

The affected systems have been distributed worldwide, including the United States, Canada, Chile, and Ecuador. Healthcare facilities using these systems should verify their equipment against the provided list of affected serial and model numbers.

FUJIFILM Healthcare Americas Corporation is notifying customers about this issue. Users should contact the manufacturer for instructions on disabling the unapproved software function.

The recalled product

Product
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Manufacturer
FUJIFILM Healthcare Americas Corporation
Category
Medical Device — Diagnostic Imaging
Hazard
  • unapproved-software
  • image-quality

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model No. CLLE-0229
  • UDI: (01)01547410297546(11)210701(21)16724035
  • (01)045474100297546(11)191001(21)967022860
  • (01)045474100297546(11)191001(21)97022857
  • (01)045474100297546(11)191001(21)97022858
  • (01)045474100297546(11)191001(21)97022861
  • (01)04547410294546(11)190801(21)96822763
  • (01)04547410294546(11)190801(21)96822764
  • (01)04547410294546(11)190801(21)96822765
  • (01)04547410294546(11)190801(21)96822767
  • (01)04547410294576(11)210501(21)16523949
  • (01)04547410294576(11)210501(21)16523950
  • (01)04547410294576(11)210601(21)16623962
  • (01)04547410294576(11)210601(21)16623963
  • (01)04547410297546(01)170601(21)76621287
  • (01)04547410297546(11)000100(21)67121008
  • (01)04547410297546(11)160107(21)66120675
  • (01)04547410297546(11)170201(21)76221098
  • (01)04547410297546(11)170220(21)67121004
  • (01)04547410297546(11)170301(21)76321131

Distribution

Distributed nationwide across the United States.

Related recalls

Same category