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.
- Recall Initiated
- December 11, 2020
- Terminated
- November 17, 2021
- Recall Number
- Z-0918-2021
- Quantity
- 1 unit
- Firm Location
- Lexington, MA
Reason for Recall
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.
Distribution
US Nationwide distribution in the state of MD.
Lot / Code Info
Versions 7.0.0 and 7.0.1
Root Cause
Software change control
Action Taken
On 12/11/2020 Fujifilm sent consignee notifications via FedEx Priority Overnight stating that there are issues with Synapse PACS Software Version 7.0.000 and 7.0.100. Fujifilm provided a work around until a hotfix is scheduled and completed.
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