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

ASPIRE Cristalle mammography systems shipped with unapproved slabbing software enabled

ASPIRE Cristalle Mammography Systems with the Digital Breast Tomosynthesis option are being recalled because devices had an unapproved slabbing software function enabled for use. 293 units affected.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall over a software function enabled without approval, with no image quality or clinical consequence stated in the source.

Plain-English summary

The ASPIRE Cristalle Mammography System, cleared under K212873 and installed with the ASPIRE Cristalle Digital Breast Tomosynthesis option approved under P160031, model number CLLE-0229, is being recalled. The action covers 293 units, identified by the UDI codes in the recall notice.

The stated reason is that devices had an unapproved slabbing software function enabled for use. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.

Distribution was worldwide, including nationwide in the United States and to Canada, Chile and Ecuador among other markets. The systems are installed in healthcare facilities rather than sold to consumers.

Facilities should identify affected systems using the model number and UDI codes above and follow the instructions issued by the manufacturer.

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 — Mammography system
Hazard
  • unapproved-software
  • regulatory-noncompliance
  • tomosynthesis
  • class-ii

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