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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 Device Recall Siemens syngo.plaza Radiological Image Processing System see related information
Date Initiated by Firm June 20, 2012
Date Posted December 03, 2012
Recall Status1 Terminated 3 on January 14, 2014
Recall Number Z-0465-2013
Recall Event ID 63521
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 PA 19355
For Additional Information Contact
610-219-6300
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		 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 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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