Recall Z-0918-2021 ยท LLZ System, Image Processing, Radiological
Fujifilm Medical Systems U.S.A., Inc.
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.
| Date | Dec 11, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Software change control |
| 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. |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190232 | Synapse PACS Fujifilm Corporation, Mar 26, 2019 |