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U.S. Department of Health and Human Services

Class 2 Device Recall syngo.via RT Image Suite V30

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 Class 2 Device Recall syngo.via RT Image Suite V30see related information
Date Initiated by FirmAugust 19, 2020
Create DateSeptember 23, 2020
Recall Status1 Terminated 3 on April 19, 2023
Recall NumberZ-3005-2020
Recall Event ID 86185
510(K)NumberK192065 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
ProductSoftware: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
Code Information Serial Numbers:  100418 100419 100420 100421 100641 100642 100643 100644 100645 100704 100713 100735 100811 100812 100813 100814 101724 102013 102031 102108 102305 102369 130125 130140 130331 130335 130628 130751 130848 130874 131012 131169 131247 131284 131325 131336 131360 131503 131578 131589 131801 131966 132011 132061 132102 132108 132136 132231 132595 132729 222224 222411 222417 222475 222491 222539 222563 222601 222638 222686 222946 223004 223084 451001 
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information ContactSAME
610-219-4834
Manufacturer Reason
for Recall		Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location
FDA Determined
Cause 2		Software design
ActionSiemens Medical Solutions USA, Inc. issued Customer Safety Advisory Letter (CSAN) SY051/20/S on August 19, 2020 via email/hand delivery by Siemens Customer Service Engineer,. The letter states reason for recall, health risk and action to take: we highly recommend performing the laser calibration and the quality assurance procedure for the laser offset after every RT Image Suite software update.Please update the calibration offset in the MM RT Image Suite Configuration dialog accordingly . Details of this procedure are documented in Chapter 13.2 (Laser configuration) of your user manual. If you have any questions or require technical support, please contact our service organization at 1-800-888-7436. The technical solution distributed via SY040/20/S. Distribution of SY040/20/S (VB40B_HF01) will be distributed to all affected customers, free of charge. Distribution of SY040/20/S began on August 26, 2020. SY040/20/S will be installed with support from your local service organization
Quantity in Commerce64 systems US
DistributionUS Nationwide distribution.
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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