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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 January 13, 2015
Date Posted January 28, 2015
Recall Status1 Terminated 3 on February 16, 2017
Recall Number Z-1027-2015
Recall Event ID 70318
510(K)Number K955394  K132532  K093612  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo.plaza: 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 Numbers: 10592457, 10863171, 10863173, 10863172; with serial numbers: Serial  100544 100262 100198 100258 200211 100135 100133 100213 100031 100084 100233 100140 200308 100245 100314 100139 100177 100197 100170 100025 100174 100186 100033 100306 100232 100185 100256 100199 100188 100257 100198 100226 100198 100228 100181 100029 100253 100301 100203 100132 100139 100247 100215 100230 100221 100146 100207 100212 100539 100206   
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		 In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk and might get lost.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action Siemens sent a Safety Advisory Notice dated January 13, 2015, to all affected customers. The Safety Notice identified the product, the problem, and the action to be taken. Siemens recommended checking patient data in the event of a system crash and advised customers that a software update is planned for mid-2015 that will resolve the issue. For questions regarding this recall call 610-219-6300.
Quantity in Commerce 50
Distribution 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
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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