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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens syngo.plaza Radiological Image Processing System

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 Class 2 Recall
Siemens syngo.plaza Radiological Image Processing System
see related information
Date Posted December 03, 2012
Recall Status1 Terminated on January 14, 2014
Recall Number Z-0465-2013
Recall Event ID 63521
Premarket Notification
510(K) Number
K093612 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
Code Information Model number 10 592 457
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
Manufacturer Reason
for Recall
Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the same patient are being continually processed for several days. This fills up the 'pcvdbsrv' log and potentially affects performance of the system. - Data could
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm, Siemens, sent "Update Instruction SY050/12/S" on June 20, 2012 to its consignees/customers. The Update Instructions described the product, problem and actions to be taken. It also provides a software update. If you have any questions call 610-219-4834 or email: anastasia.mason@siemens.com.
Quantity in Commerce 15
Distribution Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, 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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