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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 June 06, 2012
Date Posted October 11, 2012
Recall Status1 Terminated 3 on April 13, 2013
Recall Number Z-0048-2013
Recall Event ID 63045
510(K)Number K093612  
Product Classification System, image processing, radiological - Product Code LLZ
Product Siemens syngo.plaza radiological image processing system.
Code Information Model number 10592457, serial numbers 100263, 100401, 100177, 100138, 100174, 100406, 100249, 100201, 100198, 100181, 100146.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact
610-219-6300
Manufacturer Reason
for Recall		 Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.
FDA Determined
Cause 2		 Software design
Action The firm initiated this correction on June 6, 2012 by issuing update instructions SY129/12/S to consignees. A script will be distributed to all potential affected customer systems which will prevent data loss by setting the delete protection on all affected studies.
Quantity in Commerce 11
Distribution Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA.
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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