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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Syngo Dynamics

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  Class 2 Device Recall Siemens Syngo Dynamics see related information
Date Initiated by Firm April 03, 2014
Date Posting Updated May 13, 2014
Recall Status1 Terminated 3 on December 15, 2014
Recall Number Z-1613-2014
Recall Event ID 67960
510(K)Number K023772  K102150  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
Code Information model numbers: 10091805, 10091806, 10091807, 10091673 with serial numbers: 85170, 85250, 85188, 85191, 85198, 85151, 85165, 85241, 85130, 85163, 85019, 85287, 85298, 85202, 85168, 85068, 85206, 85280, 85235, 85195, 85194, 85123, 85199, 85364, 85282, 85275, 85115, 85062, 85067, 85080, 85216, 85218, 85177, 85242, 85248, 85237, 85284, 85329, 85259, 85279, 85230, 85192, 85277, 85278, 85178, 85220, 85157, 85114, 85268, 85134.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall
Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
FDA Determined
Cause 2
Software design
Action Siemens sent a Recall Notification letter dated March 26, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Siemens is preparing a Service Patch modification that would be performed to resolve the software issue.
Quantity in Commerce 50
Distribution US Nationwide Distribution in the states of AR, CA, CT, GA, IA, IL, KS, MA, MI, MN, NJ, NM, NY, OH, OR, PA, TX, TN, TX, WA, WI, and WV.
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 = ACUSON CORP.
510(K)s with Product Code = LLZ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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