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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo

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  Class 2 Device Recall Syngo see related information
Date Initiated by Firm August 31, 2017
Create Date March 01, 2018
Recall Status1 Terminated 3 on October 01, 2018
Recall Number Z-0808-2018
Recall Event ID 79178
510(K)Number K123375  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo.via systems with SW VB20A
Code Information 10496180
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		 A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system.
FDA Determined
Cause 2		 Software Design Change
Action On August 25, 2017 an URGENT letter was issued to customers notify of a system update for Syngo.via systems with SW VB20A. The software was released on August 22, 2017. Several bugs and inconsistent diagnoses were detected and this software is intended to correct these. If you have any questions, call Siemens Customer Care Centre at 888-826-9702 (24/7).
Quantity in Commerce 30
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
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