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U.S. Department of Health and Human Services

Class 2 Device Recall syngo.via VB30 or VB40

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  Class 2 Device Recall syngo.via VB30 or VB40 see related information
Date Initiated by Firm June 24, 2020
Create Date July 22, 2020
Recall Status1 Terminated 3 on April 05, 2023
Recall Number Z-2688-2020
Recall Event ID 86000
510(K)Number K192065  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product syngo.via RT Image Suite with software versions
syngo.via VB30 or VB40
Code Information syngo.via VB30 or VB40: All Lots Model #: 10496180
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact Rebecca Tudor
610-219-4834
Manufacturer Reason
for Recall		 If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in Synthetic CT , the software does not recognize the adapted acquisition plane. This may result in images with wrong geometry. When this distortion remains unnoticed and the images are subsequently exported to a treatment planning system (TPS), an incorrect calculated radiation treatment plan cannot be excluded. The occurence of this issue is very unlikely and has never been reported so far.
FDA Determined
Cause 2		 Software design
Action Siemens Healthcare Diagnostics sent a letter notification to customers dated June 23, 2020. The described issue will be solved with a service pack for software versions syngo.via VB30 and syngo.via VB40. Depending on your current software version, the service pack VB30A_HF08 will be installed with update SY039/20/S or the service pack VB40B_HF01 with update SY040/20/S as soon as it is available.
Quantity in Commerce 21 units
Distribution US Nationwide distribution including in the states of AZ, MA, WI, FL, PA. TX, MD, LA, TX, MN, MI, NY, SC, OH, GA, CA, IL, MO, CA, TX.
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 = MUJ and Original Applicant = Siemens Medical Solutions USA, Inc.
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