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U.S. Department of Health and Human Services

Class 2 Device Recall Picture archiving and communications system

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  Class 2 Device Recall Picture archiving and communications system see related information
Date Initiated by Firm January 29, 2016
Date Posted February 19, 2016
Recall Status1 Terminated 3 on February 16, 2017
Recall Number Z-0826-2016
Recall Event ID 73274
510(K)Number K023772  K102150  
Product Classification System, image processing, radiological - Product Code LLZ
Product software for Syngo Dynamics

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. Syngo Dynamics is not intended to be used for reading of mammography images.
Code Information For model #10091673
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact
610-448-6478
Manufacturer Reason
for Recall		 Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.
FDA Determined
Cause 2		 Software design
Action The firm, Siemens Healthcare, sent a "Customer Advisory Notice" dated 1/19/2019 to its customers.The notice described the product, problem and actions to be taken. The customers were instructed to create a new department if immediate resolution is necessary, use workplace for reporting and hand over the customer letter before or during installation of field modification(PSL) distributed with Update Instruction SY013/16P. A software update to resolve reported issues is being released via an Update Instruction SY013/16/P. If you have any questions, contact Regulatory Technical Specialist at 610-448-6478 or email: anastasia.sokolova@siemens.com.
Quantity in Commerce 151
Distribution US Nationwide Distribution including states of: AL AR AZ CA CO CT DE FL GA IL IN KS LA MA MD MI MN MO NC ND NE NJ NM NY OH OR PA SC TN TX UT VA WA 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 = ACUSON CORP.
510(K)s with Product Code = LLZ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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