Device product
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.
Z-0862-2016
Product summary
- Event
- Event 73041
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68
- Official record key
device-enforcement:Z-0862-2016
Official wording
Reason: Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region is now properly fitted to segment boundary when clicking fit breast to screen.
Code information: Device model numbers: 10863171, 10863172, 10863173
Distribution pattern: Nationwide Distribution including AL CA CT FL IN KS LA MA MD MI MN MO MS NE NY OH OR PA TX WA WI
Derived failure modes
-
Device software or design
software version to address several software issues including RGB images will