FDA Recall
Terminated
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: Z-0918-2021
·
Initiated December 11, 2020
Recall
- Recall Number
- Z-0918-2021
- Event Number
- 87083
- Firm
- Fujifilm Medical Systems U.S.A., Inc.
- FEI Number
- 1000513161
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Software change control
- Initiated
- December 11, 2020
- Terminated
- November 17, 2021
- Address
- 81 Hartwell Ave, Ste 300, Lexington, MA, 02421-3160
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.
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.
Action
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.
Distribution
US Nationwide distribution in the state of MD.
Quantity
1 unit