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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 July 26, 2012
Recall Status1 Terminated on January 14, 2014
Recall Number Z-2078-2012
Recall Event ID 62462
Premarket Notification
510(K) Number
K101666 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Siemens syngo.plaza. Radiological image processing system
Code Information Model number 10592457
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
Manufacturer Reason
for Recall
Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.
FDA Determined
Cause 2
DESIGN: Software Design
Action Siemens sent a Customer Safety Advisory Notice letter dated February 24, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to ensure that the prefix defined in the viewer settings for "Content Creator's Initials" is not empty. Then all images will be display correctly. This has to be checked for every user. Further questions please call 610-219-6300.
Quantity in Commerce 2
Distribution (USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
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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