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U.S. Department of Health and Human Services

Class 2 Device Recall syngo Imaging XS

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 Class 2 Device Recall syngo Imaging XSsee related information
Date Initiated by FirmJuly 18, 2012
Date PostedAugust 24, 2012
Recall Status1 Terminated 3 on November 06, 2014
Recall NumberZ-2264-2012
Recall Event ID 62678
510(K)NumberK082430 
Product Classification System, image processing, radiological - Product Code LLZ
Productsyngo Imaging XS. Radiological image processing system.
Code Information Model number 10496279
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information ContactCustomer Support
610-219-4834
Manufacturer Reason
for Recall		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".
FDA Determined
Cause 2		Software design
ActionSiemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" dated July 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. For questions concerning this notice contact your local Siemens Service Rep..
Quantity in Commerce52
DistributionNationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LLZ
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