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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Syngo.CT

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 Class 2 Device Recall Siemens Syngo.CTsee related information
Date Initiated by FirmAugust 16, 2021
Date PostedSeptember 10, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2446-2021
Recall Event ID 88588
510(K)NumberK200524 
Product Classification System, x-ray, tomography, computed - Product Code JAK
Productsyngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670
Code Information Serial Numbers: 128051 130051 128065 128035 130057 128086 128079 128041 128019 128078 128060 128068 112045 128085 128075 128022 128033 130012 128016 130044 130048 130049 128018 119216 108085 128015 130019 130055 130054 128020 128039 130052 130036 130061 128049 117756 128029 130021 130045 130039 128063 128057 128045 128046 ***UPDATED 12/9/21*** 128114 128113 130058 ***Updated 1/31/22: Serial Number 128123 130015 130081 112261 112071 128124 128132 128125 130079 130077 Expanded Recall 3/12/22: 11061620 S/N: 111805 11061660 S/N: 128144, 128135, 128142, 128136, 128133 11061670 S/N: 130088, 130094, 130090, 130087, 130091, 130092, 130089
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactSAME
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
ActionSiemens 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 Commerce44 systems
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 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) Database510(K)s with Product Code = JAK
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