Device product
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
Z-0073-2017
Product summary
- Event
- Event 75192
- Status
- Terminated
- Classification
- Class II
- Quantity
- 251 units
- Official record key
device-enforcement:Z-0073-2017
Official wording
Reason: Image data for a patients image may not be correct
Code information: Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
Image data for a patients image may not be correct