ASPRIRE Cristalle Mammography System — Class II medical device recall Z-2219-2025
Ongoing recall by FUJIFILM Healthcare Americas Corporation, reported 2025-08-06, distributed nationwide. Devices had an unapproved slabbing software function enabled for use.
| Recall number | Z-2219-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | FUJIFILM Healthcare Americas Corporation, Lexington, MA, United States |
| Recall initiated | 2025-06-11 |
| Classified | 2025-07-30 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, EC |
| Quantity | 293 units |
| Reason classes | software, unapproved product |
| UPC / GTIN / UDI-DI | 04547410294576, 04547410297546 |
| Serial numbers | 16223805, 16323842, 16323843, 16323844, 16323845, 16523949, 16523950, 16623962, 16623963, 16623964, 16623965, 16623966, 16623967, 16623968, 16623969, 16623970, 16623971, 16623972, 16623973, 16623974, 16623975, 16623977, 16623978, 16623979, 16623980 and 261 more |
| Model numbers | CLLE-0229 |
Product
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Reason for recall
Devices had an unapproved slabbing software function enabled for use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2219-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.