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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo.plaza

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  Class 2 Device Recall Syngo.plaza see related information
Date Initiated by Firm August 23, 2017
Create Date February 05, 2018
Recall Status1 Terminated 3 on October 01, 2018
Recall Number Z-0524-2018
Recall Event ID 78677
510(K)Number K132532  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173

Product Usage:
Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
Code Information Model Number - 10863171, 10863172, 10863173
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Anastasia Sokolova
610-448-6461
Manufacturer Reason
for Recall		 When a prior study is being replaced in the workflow step, in certain scenarios (based on the Display Protocol configuration) the prior study will only be replaced in the active Workflow Step and not show in all other workflow steps. The other workflow steps will continue to show the initially loaded study.
FDA Determined
Cause 2		 Software design
Action Siemens Healthineers distributed Urgent Customer Advisory Notices to their customers via courier service. Customers were advised to always verify date and time of the displayed study during workflow step change to ensure that the desired images are being displayed. Otherwise, please replace the displayed initial study in the workflow step with the expected study. Customers with any questions, call Siemens Customer Care Centre at 888-826-9702.
Quantity in Commerce 76
Distribution US 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 AG HEALTHCARE
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