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U.S. Department of Health and Human Services

Class 2 Device Recall syngo Dynamics Version 9.5

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  Class 2 Device Recall syngo Dynamics Version 9.5 see related information
Date Initiated by Firm July 13, 2012
Date Posted August 17, 2012
Recall Status1 Terminated 3 on July 15, 2013
Recall Number Z-2219-2012
Recall Event ID 62581
510(K)Number K102150  
Product Classification System, image processing, radiological - Product Code LLZ
Product syngo Dynamics Version 9.5
Code Information 10091862 and 10091863
Recalling Firm/
Manufacturer		 Siemens Medical Solutions, USA, Inc
400 Morgan Rd
Ann Arbor MI 48108
For Additional Information Contact Yuri Ikeda
800-422-8766
Manufacturer Reason
for Recall		 If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study.
FDA Determined
Cause 2		 Software design
Action On 07/13/2012, Siemens issued a "Customer Safety Advisory Notice" to affected consignees according to Update Instruction SY062/121S. The notice informs the customers of the potential issue with the identified affected product and provides details regarding the resolution. A software update to relieve the symptom of the issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY063/121S. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY064/121S.
Quantity in Commerce 30
Distribution Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.
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 MEDICAL SOLUTIONS USA, INC.
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