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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Syngo.via RT Image Suite

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  Class 2 Device Recall Siemens Syngo.via RT Image Suite see related information
Date Initiated by Firm August 16, 2021
Date Posted September 10, 2021
Recall Status1 Open3, Classified
Recall Number Z-2445-2021
Recall Event ID 88588
510(K)Number K211379  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60-
Intended for Radiation Therapy Treatment
Material Number: 10496180
Code Information Serial Numbers: 100713 223736 222946 223440 223032 223347 223084 223811 130643 223004 451078 101724 132011 131247 451036 132231 451032 222835 130848 500010 101773 132729 130874 133176 100421 100419 100420 100643 100642 100811 100814 100644 102369 100812 100641 100418 100813 100645 131284 130712 223734 102305 132893 223310 222411 223258 223334 223090 132781 131867 222563 222417 222491 131503 130125 451070 222224 132108 500013 132061 131169 451023 451017 451077 132701 102113 451094 130628 500007 131213 131360 500020 500028 451079 132205 451031 451001 222914 130331 451034 133191 102108 132136 131325 222686 223207 130734 102021 131578 500005 451071 222521 132904 102031 222539 222860 451039 130335 222862 222638 100677 222729 131336 223188 130452 223220 131801 131589 222719 132102 130140 223844 500004 451074 451030 133198 222601 133261 132595 130751 223150 131966 223424 223259 223058 131012 ***Updated 12/9/21*** 223021 ***Updated 1/31/22: Serial number 222475 133503
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact SAME
610-219-4834
Manufacturer Reason
for Recall		 Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).
FDA Determined
Cause 2		 Software design
Action Siemens has initiated three (3) Customer Safety Advisory Notices (CSANs) to affected customers via SY052/21/S, CT042/21/S and MR019/21/S by email or hand delivery by the Siemens Customer Service Engineer on 8/16/21. Temporary workarounds are available for some of the software versions and are described in the CSANs. Additionally, a solution to eliminate the root cause of this problem is being distributed via SY051/21/S (for SY and CT) and MR021/21/S for MR to all affected customers free of charge. The service organization will contact you to arrange a date to perform this corrective action free of charge. Contact the service organization for an earlier appointment at 1-800-888-7436. ***UPDATE: 01/31/22 Additionally, a solution to eliminate the root cause of this problem is being distributed via CT049/21S, CT061/21/S, CT062/21/S, and CT088/21/S for CT. ***UPDATE: 03/12/22 Status Report Additional 13 S/N's added
Quantity in Commerce 126 units
Distribution US 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = Siemens Medical Solutions USA Inc.
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