Fujifilm Synapse PACS software version 4 — Class II medical device recall Z-2043-2016
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2016-06-29, distributed in CA, FL, KS, NE, NY, PA. Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message di
| Recall number | Z-2043-2016 |
|---|---|
| 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 | 2016-05-10 |
| Classified | 2016-06-21 |
| Reported by FDA | 2016-06-29 |
| Terminated | 2019-02-20 |
| Distributed | CA, FL, KS, NE, NY, PA |
| Quantity | 27 units |
Product
Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an off-the-shelf PC networked with Fuji Synapse PACS.
Reason for recall
Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
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-2043-2016. 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.