FUJIFILM Synapse PACS Software: versions 7 — Class II medical device recall Z-0918-2021
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2021-02-03, distributed nationwide. The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when th
| Recall number | Z-0918-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc., Lexington, MA, United States |
| Recall initiated | 2020-12-11 |
| Classified | 2021-01-22 |
| Reported by FDA | 2021-02-03 |
| Terminated | 2021-11-17 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| Reason classes | software |
Product
FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
Reason for recall
The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.
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-0918-2021. 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.