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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00753-3
Product Name/Description syngo Plaza (Radiology picture archiving and communication system)

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 for each issue and will be implementing a software update to correct the problem.
Contact Information 1800 310 300 - Zahra Hyland