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Recall Observatory FDA recall evidence

Device product

syngo Imaging XS. Radiological image processing system.

Z-2264-2012

July 18, 2012

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 62678
Status
Terminated
Classification
Class II
Quantity
52
Official record key
device-enforcement:Z-2264-2012

Official wording

Reason: There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".

Code information: Model number 10496279

Distribution pattern: Nationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".