FDAFDA · Food and drugs·Recall number Z-2111-2014
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.
Published July 30, 2014 · Recall initiated: June 30, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide Distribution
- Lot
- model number: 10496279
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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