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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 Siemens Ltd
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