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 |
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