Fujifilm Medical Systems U.S.A., Inc. Recall 87083
Description: 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.
Fujifilm Medical Systems U.S.A., Inc. Recall 87083 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0918-2021 |
| Event ID | 87083 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of MD. |
| Quantity | 1 unit |
| Recall Reason | 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. |
| Device Classification | 20210203 |
| Device Code Info | Versions 7.0.0 and 7.0.1 |
| Center Classification Date | 20210122 |
| Recall Initiation Date | 20201211 |
| Recalling Firm | Fujifilm Medical Systems U.S.A., Inc. |
| Initial Notification | Letter |
| Similar To |