Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse… — Class II medical device recall Z-1612-2015
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2015-05-20, distributed nationwide. Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demog
| Recall number | Z-1612-2015 |
|---|---|
| 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 | 2015-02-04 |
| Classified | 2015-05-14 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2018-09-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 16 units |
Product
Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable
Reason for recall
Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report.
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-1612-2015. 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.