Device product
Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an off-the-shelf PC networked with Fuji Synapse PACS.
Z-2043-2016
Product summary
- Event
- Event 74372
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 units
- Official record key
device-enforcement:Z-2043-2016
Official wording
Reason: Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
Code information: Software version: 4.4.000, 4.4.001, 4.4.004, 4.4.010, 4.4.020
Distribution pattern: US Distribution to states of: CA, FL, KS, NE, NY, and PA.
Derived failure modes
-
Unknown
Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead