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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 Recall
syngo.plaza VA20A, model number 10592457
see related information
Date Posted January 20, 2012
Recall Status1 Terminated on January 24, 2014
Recall Number Z-0827-2012
Recall Event ID 60761
Premarket Notification
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/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Meredith A. Adams
610-219-6300
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
DESIGN: 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 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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