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.
Enforcement
- Recall Number
- Z-2043-2016
- Event ID
- 74372
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fujifilm Medical Systems U.S.A., Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 29, 2016
- Initiation Date
- May 10, 2016
- Classification Date
- June 21, 2016
- Termination Date
- February 20, 2019
- Address
- 419 West Ave, N/A, Stamford, CT, 06902-6343, United States
Description
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.
Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
Software version: 4.4.000, 4.4.001, 4.4.004, 4.4.010, 4.4.020
US Distribution to states of: CA, FL, KS, NE, NY, and PA.
27 units