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U.S. Department of Health and Human Services

Class 2 Device Recall syngo.plaza VA20A, model number 10592457

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  Class 2 Device Recall syngo.plaza VA20A, model number 10592457 see related information
Date Initiated by Firm May 01, 2011
Date Posted January 20, 2012
Recall Status1 Terminated 3 on January 24, 2014
Recall Number Z-0827-2012
Recall Event ID 60761
510(K)Number K101666  
Product Classification System, image processing, radiological - Product Code LLZ
Product Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.
Code Information Model number 10592457, serial numbers 100174, 100177, and 100181.
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Meredith A. Adams
Manufacturer Reason
for Recall
The firm has become aware of the potential for an unintended merge of multiple patients when using syngo.plaza version VA20 with Server Farm setup integrated to a RIS. Sporadically it can happen that certain Patient IDs in the database are deleted and sent to NULL. This can cause incorrect merging with patients that already had a NULL Patient ID.
FDA Determined
Cause 2
Software design
Action The firm initiated their product recall in May 2011 by issuing a "Customer Safety Advisory Notice" informing all customers of the malfunction and providing instructions on how to avoid the error. The issue will be solved with the next version release, planned for June 2011.
Quantity in Commerce 3
Distribution Nationwide Distribution - Including the states of Florida, Massachusetts and Wisconsin.
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