Recall Z-2111-2014 · LLZ System, Image Processing, Radiological

Siemens Medical Solutions USA, Inc

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 opti

Date	Jul 23, 2014 (initiated Jun 30, 2014)
Status	Terminated
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 d
Root cause	Software design
Action	Siemens sent a Customer letter dated June 30th, to all affected customers to inform them of a new software version VA70B_0114 that will be introduced to all syngo Imaging XS customers with version VA70A or higher to solve a potential issue regarding miscalculations done for the grey scale values in the functions "Region of Interest", "Pixel Lens", "Edge Enhancement", and "Histograms". For questions regarding this recall call 610-219-6300.
Quantity	141
Distribution	Nationwide Distribution
FDA record	Open on fda.gov

510(k) clearances named in this recall

K082430

SYNGO IMAGING XS
Siemens AG Medical Solutions, Nov 14, 2008