Fujifilm Synapse PACS — Class II medical device recall Z-0073-2017
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2016-10-19, distributed nationwide. Image data for a patients image may not be correct
| Recall number | Z-0073-2017 |
|---|---|
| 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 | 2016-09-15 |
| Classified | 2016-10-12 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2019-02-20 |
| Distributed | Nationwide (US) |
| Quantity | 251 units |
Product
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
Reason for recall
Image data for a patients image may not be correct
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-0073-2017. 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.