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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo.via software

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 Class 2 Device Recall Syngo.via softwaresee related information
Date Initiated by FirmJanuary 10, 2018
Create DateMarch 28, 2018
Recall Status1 Terminated 3 on October 02, 2018
Recall NumberZ-1261-2018
Recall Event ID 79513
510(K)NumberK123375 
Product Classification System, image processing, radiological - Product Code LLZ
ProductSyngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
Code Information All Syngo.via systems with VB20A. Model number 10496180.
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact
610-219-4834
Manufacturer Reason
for Recall		When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. Due to the disabled cleanup function, disc capacity for free space decreases faster than usual. Unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged "Not to be archived" must be manually prevented from being deleted by either clinical administrator or service engineer.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionCustomers received letters with information related to the issue and regarding the upgrade to the software version VB20A_HF04. The software was released December 22, 2017 and is available for install.
Quantity in Commerce165 units
DistributionMedical device software which needs to be installed.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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