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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 088 07 12 000
Date submitted: 7/23/2012
Manufacturer:SIEMENS
Device Type:Picture archiving and communication system, radiology, Syngo. Plaza and Syngo Imaging XS
Description:picture archiving and communication system
Medical Device Identifier: (1) System Label 10592 457 System version:VA20D (2) System Label104 96 279 System version:All versions VA70 and higher are affected
Reason of Field Safety Corrective Action: The issue is isolated images of pixel depth greater than 12 bit (99% of all stored images). Problem exists prior to VA20D as welL" Analysis showed that this behaviour is caused by a software bug. In some situations it can happen that a miscalculation is done 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 the functions "Region of Interest", "Pixel Lens", "Edge enhancement" and "Histograms" is not correct for images with a pixel depth greater than 12 bit. It has to be noted that 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.
Remedy Action: (1) For Syngo.Plaza Change of software-behavior in software update synKo.pJaza, VA20D HFO I. (2) For Syngo Imaging XS Change of software-behavior in software update Syngo Imaging XS VA70B _0113.
Athorized Representative/Importer/Distributor:Siemens Medical Solutions, Riyadh, (01)2778268
Report Source:NCMDR
Source Ref. Number:C668E0F8AA3B0, 0F2BBC3ADE20E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments