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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 18, 2015
Date Posted March 30, 2015
Recall Status1 Terminated 3 on August 17, 2016
Recall Number Z-1354-2015
Recall Event ID 70596
510(K)Number K955394  K132532  K093612  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo.plaza. 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.
Code Information Model Numbers of device: 10592457, 10863172, serial numbers: 100177 100033 100181 100029   
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.
FDA Determined
Cause 2		 Software design
Action Safety Advisory Notice, dated February 18, 2015, was sent to end users that identified the product, problem, and action to be taken. Users were advised not to manually remove the delete protection in the STS.
Quantity in Commerce 4
Distribution US Distribution: MA, WI, FL
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
510(K)s with Product Code = LLZ and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
510(K)s with Product Code = LLZ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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