Z-2043-2016 Class II Terminated
FDA device recall Z-2043-2016 was initiated by Fujifilm Medical Systems U.S.A., Inc. on May 10, 2016 and is designated Class II. Reason for recall: Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead The recall status is terminated (terminated Feb 20, 2019). Affected quantity: 27 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 29, 2016
- Initiation Date
- May 10, 2016
- Termination Date
- Feb 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 units
Product 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.
Reason for Recall
Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
Distribution Pattern
US Distribution to states of: CA, FL, KS, NE, NY, and PA.
Code Information
Software version: 4.4.000, 4.4.001, 4.4.004, 4.4.010, 4.4.020
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2043-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026