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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens syngo.plaza

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  Class 2 Device Recall Siemens syngo.plaza see related information
Date Initiated by Firm September 21, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on January 31, 2014
Recall Number Z-0522-2012
Recall Event ID 60426
510(K)Number K093612  
Product Classification system image processing radiological - Product Code LLZ
Product syngo.plaza

Image processing system
Code Information Model number 10592457
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Anastasia Mason
610-219-4834
Manufacturer Reason
for Recall		 Potential malfunction when using syngo.plaza. On syngo.plaza workplaces large studies can be loaded into the viewer if transferred from a DICOM node or imported even while image transfer is not yet completed. In these situations more images of that study may exist which are not shown in the syngo.plaza viewer.
FDA Determined
Cause 2		 Software design
Action Siemens Medical Solutions USA sent a Customer Safety Advisory Notice dated March 10, 2011 to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed the customer of the potential issues and provides additional information on the implemented resolution. For further questions please call (610) 219-4834.
Quantity in Commerce 1
Distribution Nationwide Distribution New York
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LLZ and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
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