| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00752-3 |
| Product Name/Description |
syngo Imaging XS (Radiology picture archiving and communication system). Version VA70A or higher
ARTG Number: 120332 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified that in some situations a miscalculation may occur for the grey scale values in the functions "Region of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms". The Min/Max value of pixel density in these functions is not correct for images with a pixel depth greater than 12 bit. The mentioned measurements shown in prior images are also not correct. All values which are calculated for images with a pixel depth less than or equal to 12 bits are correct. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing work around instructions until a software update can be implemented to permanently fix the issue. This action has been closed-out on 18/02/2016. |
| Contact Information |
1800 310 300 - Zahra Hyland |