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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens syngo Imaging XS, all versions

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  Class 2 Device Recall Siemens syngo Imaging XS, all versions see related information
Date Initiated by Firm September 20, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on March 05, 2014
Recall Number Z-0514-2012
Recall Event ID 60425
510(K)Number K082430  
Product Classification System, image processing, radiological - Product Code LLZ
Product syngo Imaging XS, all versions

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 Contact Anastasia Mason
610-219-4834
Manufacturer Reason
for Recall		 Unintended behavior when using syngo Imaging XS, all versions. The "Rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Siemens Medical Solutions USA, Inc sent a Customer Safety Advisory Notice letter dated August 3, 2011 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you detect patient data inconsistencies in your system caused by this problem, please contact Siemens Service for support. For further questions please call (610) 219-4834.
Quantity in Commerce 38
Distribution Nationwide Distribution including the states of CA, FL, GA, IN, IA, KS, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
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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