ASPIRE Cristalle — Class II medical device recall Z-0386-2018
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2018-01-24. There was a case that the swivel arm went down unintentionally when it was moved up/down.
| Recall number | Z-0386-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc., Stamford, CT, United States |
| Recall initiated | 2017-07-14 |
| Classified | 2018-01-18 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2018-07-20 |
| Countries outside the US | MX |
Product
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
Reason for recall
There was a case that the swivel arm went down unintentionally when it was moved up/down.
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-0386-2018. 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.