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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens syngo Dynamics Workplace, version 5.0

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  Class 2 Device Recall Siemens syngo Dynamics Workplace, version 5.0 see related information
Date Initiated by Firm July 23, 2008
Date Posted January 02, 2009
Recall Status1 Terminated 3 on October 18, 2010
Recall Number Z-0544-2009
Recall Event ID 49457
510(K)Number K053133  
Product Classification Image Processing Radiological System - Product Code LLZ
Product Siemens syngo Dynamics Workplace, version 5.0, Siemens Medical Solutions, Ann Arbor, MI; 10090310.

Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
Code Information All units.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions, USA, Inc
400 Morgan Rd
Ann Arbor MI 48108
For Additional Information Contact
800-422-8766
Manufacturer Reason
for Recall		 If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.
FDA Determined
Cause 2		 Software design
Action Consignees were notified of the problem via a Customer Safety Advisory Notice dated 7/23/08, which provided guidance on how to minimize the risk of the problem occurring, and told customers that a service patch will be installed when it becomes available.
Quantity in Commerce 306 of all products.
Distribution Nationwide Distribution.
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 MEDICAL SOLUTIONS USA, INC.
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