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U.S. Department of Health and Human Services

Class 2 Device Recall syngo.via RT Image Suite

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 Class 2 Device Recall syngo.via RT Image Suitesee related information
Date Initiated by FirmMarch 07, 2022
Create DateApril 22, 2022
Recall Status1 Terminated 3 on December 19, 2023
Recall NumberZ-0994-2022
Recall Event ID 89915
510(K)NumberK211379 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Code Information Serial Number 133527
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactRebecca Tudor
610-219-4834
Manufacturer Reason
for Recall		Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
FDA Determined
Cause 2		Software change control
Action4/4/22 update: Urgent Medical Device Correction letter has not been issued. The proposed letter informs customers of software issue and workaround to resolve issue. It also requires electronic signature to acknowledge receipt of the notification. If you have additional questions contact the service organization at 1-800-888-7436.
Quantity in Commerce1 (US)
DistributionWorldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Switzerland, United Kingdom.
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 = MUJ
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