FDA Device recall Z-2043-2016
Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.…
- FDA Device
- Class II
- terminated
- Published 2016-06-29
On 2016-06-29 the FDA classified a Class II recall of Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.… by Fujifilm Medical Systems U, citing synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2043-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-10 |
| Published | 2016-06-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | CA, FL, KS, NE, NY, PA |
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.
Reason
Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
Identifiers
| code_info | Software version: 4.4.000, 4.4.001, 4.4.004, 4.4.010, 4.4.020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2043-2016%22
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