Device product
syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .
Z-1232-2016
Product summary
- Event
- Event 73481
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6
- Official record key
device-enforcement:Z-1232-2016
Official wording
Reason: After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
Code information: Serial # 20119, 20098, 20041, 20124, 12177, 20026
Distribution pattern: Nationwide Distribution to IL, NY, MT, and MN.
Derived failure modes
-
Unknown
After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.