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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo.Via VB20A model 1049610

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  Class 2 Device Recall Syngo.Via VB20A model 1049610 see related information
Date Initiated by Firm March 27, 2018
Date Posted May 09, 2018
Recall Status1 Terminated 3 on June 15, 2020
Recall Number Z-1778-2018
Recall Event ID 79888
510(K)Number K123375  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo.Via VB20A model 1049610
Code Information All
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Anastasia Sokolova
610-219-4834
Manufacturer Reason
for Recall		 Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still use original values.
FDA Determined
Cause 2		 Software design
Action On 03/27/18 Firm became aware that recall was necessary Firm initiated recall on 03/27/18 via customer information letter SY007/18/P advising that corrected values modified in the report are not save. Software patch VB20A_HF05 is being released to resolve the matter
Distribution 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
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