Device product
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
Z-1972-2015
Product summary
- Event
- Event 71507
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-1972-2015
Official wording
Reason: During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.
Code information: model number: 10014064 serial numbers: 5846 5847 4333 4334 4335
Distribution pattern: US in the states of NC and NE
Derived failure modes
-
Unknown
During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.