Reported Aug 6, 2025 · Ongoing
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast…
FUJIFILM Healthcare Americas Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: FUJIFILM Healthcare Americas Corporation · 81 Hartwell Ave Ste 300 · Lexington, MA · 02421-3160
Is this the product you have?
- ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
- Lot codes and dates
- Model No. CLLE-0229
- UDI
503 of 503 codes
(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(01)04547410297546(11)170301(21)76321132(01)04547410297546(11)170301(21)76321136(01)04547410297546(11)170501(21)76521235(01)04547410297546(11)170501(21)76521236(01)04547410297546(11)170501(21)76521237(01)04547410297546(11)170501(21)76521238(01)04547410297546(11)170720(21)76621277(01)04547410297546(11)170731(21)76621278(01)04547410297546(11)170801(21)76821374(01)04547410297546(11)170801(21)76821375(01)04547410297546(11)170923(21)76121056(01)04547410297546(11)171001(21)77021484(01)04547410297546(11)171001(21)77021485(01)04547410297546(11)171001(21)77021486(01)04547410297546(11)171006(21)76821376(01)04547410297546(11)171101(77)121559(01)04547410297546(11)171101(77)121560(01)04547410297546(11)171101(77)121561(01)04547410297546(11)180101(01)86121657(01)04547410297546(11)180101(86)121658(01)04547410297546(11)180101(86)121659(01)04547410297546(11)180101(86)121660(01)04547410297546(11)180423(21)76421207(01)04547410297546(11)180502(21)86321784(01)04547410297546(11)180518(21)76421208(01)04547410297546(11)181026(21)86421848(01)04547410297546(11)190103(21)77221602(01)04547410297546(11)190109(21)77221600(01)04547410297546(11)190215(21)86221736(01)04547410297546(11)190426(21)86421849(01)04547410297546(11)190523(21)86221735(01)04547410297546(11)190605(21)86622007(01)04547410297546(11)190607(21)67121009(01)04547410297546(11)190614(21)87022245(01)04547410297546(11)190716(21)86622008(01)04547410297546(11)190801(21)96822766(01)04547410297546(11)190801(21)96822768(01)04547410297546(11)190801(21)96822769(01)04547410297546(11)190802(21)96522600(01)04547410297546(11)190805(21)96422570(01)04547410297546(11)190816(21)67121002
- Amount recalled
- 293 units
Where it was sold
- Nationwide
Why it was recalled
Devices had an unapproved slabbing software function enabled for use.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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