Company Siemens Medical Solutions USA, Inc
Date of Enforcement Report 7/302014
Class lI:
PRODUCT
Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced post processing applications. Recall Number Z-2111-2014
REASON
Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur for the grey scale values in the functions Region of Interest , Pixel Lens , Edge enhancement and Histograms . This potential malfunction may occur for images with a pixel depth greater than 12 bit. All values calculated for images with a pixel depth less than or equal to 12 bit are correct.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Nalvern, PA on 6/30/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
141
DISTRIBUTION
Nationwide
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