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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 May 22, 2017
Create Date November 21, 2017
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-0168-2018
Recall Event ID 77456
510(K)Number K132532  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171


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 work flows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
Code Information non-medical software application Check Tool V1 .0 (L TA Incomplete Archive Check Tool V1 .0)
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Anastasia Sokolova
610-448-6478
Manufacturer Reason
for Recall		 Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom LTA. It has been defined that the number of de-archived images is less than the count of the archived images for the series. The issues were discovered through Siemens Global Complaint Handling System.
FDA Determined
Cause 2		 Software design
Action Siemens sent an Customer Information Letter dated May 17, 2017. Customers Instructions: If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions, please call (610) 448-6478.
Quantity in Commerce 2 units
Distribution Distribution to MN
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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