Synapse Cardiovascular — Class II medical device recall Z-1775-2021
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2021-06-09, distributed nationwide. Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal pat
| Recall number | Z-1775-2021 |
|---|---|
| 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 | 2021-04-30 |
| Classified | 2021-06-02 |
| Reported by FDA | 2021-06-09 |
| Terminated | 2024-07-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, CA, IL |
| Reason classes | software |
Product
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Reason for recall
Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence
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-1775-2021. 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.