FDA Device recall Z-1612-2015
Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Pict…
- FDA Device
- Class II
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class II recall of Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Pict… by Fujifilm Medical Systems U, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1612-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-04 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | US |
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
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.
Identifiers
| code_info | Software Versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1612-2015%22
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