Device product
syngo Imaging XS. Radiological image processing system.
Z-2264-2012
Product summary
- Event
- Event 62678
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52
- Official record key
device-enforcement:Z-2264-2012
Official wording
Reason: There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".
Code information: Model number 10496279
Distribution pattern: Nationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
Derived failure modes
-
Unknown
There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".