Recall Z-0282-2021 ยท LLZ System, Image Processing, Radiological
Fujifilm Medical Systems U.S.A., Inc.
Synapse PACS Software Version 5.6.1 - 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 | Sep 11, 2020 |
| Status | Terminated |
| Reason | FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected. |
| Root cause | Software change control |
| Action | Letter was sent to all affected customers on 09/11/2020 stating the following: FUJIFILM will offer an upgrade to Synapse PACS 7.1.100 to resolve this issue. Synapse PACS 7.1.100 is estimated to be available by the end of September. Until the patch is available, users can continue to safely use Synapse PACS by following these additional instructions: 1. Ensure that the 3D Sphere MAX value is within the spheres range. If the 3D Sphere MAX value is observed to be much higher than expected, the value should not be used when rendering a clinical decision until the issue is corrected. Customers |
| Quantity | 1 |
| Distribution | US Nationwide distribution including in the state of Minnesota. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190232 | Synapse PACS Fujifilm Corporation, Mar 26, 2019 |