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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo.plaza Picture Archiving and Communication System

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  Class 2 Device Recall Syngo.plaza Picture Archiving and Communication System see related information
Date Initiated by Firm August 18, 2017
Create Date January 31, 2018
Recall Status1 Terminated 3 on August 30, 2018
Recall Number Z-0495-2018
Recall Event ID 79054
510(K)Number K132532  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173

Syngo.plaza is a Picture Archiving and Communication System (PACS) software device 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 Syngo.plaza with software version VB20A; Model numbers: 10863171, 10863172, 10863173
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Anastasia Sokolova
610-219-6461
Manufacturer Reason
for Recall		 Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of data due to inadequate permissions for shared folders.
FDA Determined
Cause 2		 Software design
Action Siemens released a software update VB20A_HF04 and a Customer Information Letter was sent with Update Instruction SY010/17/P. Service reports for the affected sites will be monitored to ensure the recall was effective. For further questions, please call (610) 219-6461.
Quantity in Commerce 47
Distribution USA (nationwide) Distribution to the states of : AL, CT, FL, KS, LA, MA, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX and WI. Foreign consignees were not reported as device is manufactured outside the U.S.
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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