FDA Medical devices recall ·
ASPRIRE Cristalle Mammography System (cleared under K212873) installed… recall
- Recall number
- Z-2219-2025
- Date
- (initiated June 11, 2025)
- Company / brand
- FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300, Lexington, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 293 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Why was it recalled?
Devices had an unapproved slabbing software function enabled for use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, (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, (
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2219-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.