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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 September 06, 2016
Date Posted September 27, 2016
Recall Status1 Terminated 3 on May 08, 2017
Recall Number Z-2891-2016
Recall Event ID 75171
510(K)Number K093612  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo.plaza, Picture Archiving and Communication System
Code Information Serial Numbers: 100262 100198 100258 100259 100538 100133 100213 100214 100031 100484 100362 100416 100461 100457 100447 100139 100027 100559 100440 100441 100025 100084 100186 100189 100190 100191 100192 100195 100196 100033 100232 100449 100450 100199 100256 100228 100425 100029 100253 100203 100204 100132 100434 100491 100495 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 upgrade to eliminate several issues
FDA Determined
Cause 2		 Software design
Action Siemens notified customers via mail on 09/07/2016 informing them of the latest syngo.plaza software change that was available to address several issues.
Quantity in Commerce 47 systems
Distribution Distributed Nationwide
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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