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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo.plaza, picture archiving and communications system

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  Class 2 Device Recall Syngo.plaza, picture archiving and communications system see related information
Date Initiated by Firm January 11, 2017
Create Date January 31, 2017
Recall Status1 Terminated 3 on November 16, 2017
Recall Number Z-1116-2017
Recall Event ID 76278
510(K)Number K093612  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo.plaza, picture archiving and communications system.
Code Information Model Number: 10863171, 10863172, 10863173 Serial Numbers:  100262 100198 100258 100259 100135 100538 100133 100031 100105 100106 100109 100110 100111 100112 100113 100114 100115 100116 100117 100119 100120 100416 100461 100245 100447 100364 100298 100299 100386 100139 100027 100440 100441 100559 100025 100033 100196 100189 100190 100191 100192 100195 100186 100232 100450 100449 100256 100199 100188 100194 100198 100029 100253 100203 100204 100132 100139 100434 100476 100495 100491 100206 
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 update for improvements and to resolve several issues
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens mailed a Customer Letter to affected customers on 01/13/2017 to provide information about the latest software change that is now available to address several issues.
Quantity in Commerce 62 systems
Distribution Distributed throughout the United States.
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, MEDICAL SOLUTIONS
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