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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 February 20, 2018
Create Date May 07, 2018
Recall Status1 Terminated 3 on July 16, 2019
Recall Number Z-1699-2018
Recall Event ID 79740
510(K)Number K132532  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173

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 All Serial Numbers  
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		 Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
FDA Determined
Cause 2		 Software design
Action On February 25, 2018 a Customer Information Letter was mailed to customers. This notification informed customers of the software changes related to All Sygno.plaza systems with VB20A. Customers were asked to install an updated software patch and instructed to share the notification with all users of the affected product. Customers with questions should call Siemens Customer Care Centre at (866)823-9702. For further questions, please call (610) 448-6461.
Quantity in Commerce 92
Distribution USA (nationwide)
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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