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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 Recall
Siemens syngo.plaza
see related information
Date Posted October 11, 2012
Recall Status1 Terminated on April 13, 2013
Recall Number Z-0048-2013
Recall Event ID 63045
Premarket Notification
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, Pennsylvania 19355
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
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