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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM

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  Class 2 Device Recall SOMATOM see related information
Date Initiated by Firm March 03, 2021
Create Date March 15, 2021
Recall Status1 Terminated 3 on December 28, 2023
Recall Number Z-1253-2021
Recall Event ID 87454
510(K)Number K200524  K192061  K173632  K163296  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows:

SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628)
SOMATOM go.All (Model 11061630)
SOMATOM go.Top (Models 11061640 & 11061648)
SOMATOM go.Sim (Model 11061660)
SOMATOM go.Open Pro (Model 11061670)
SOMATOM X.cite (Model 11330001)
Code Information Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact SAME
610-219-4834
Manufacturer Reason
for Recall		 SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. Sporadic software errors during interventional workflows may also result
FDA Determined
Cause 2		 Software design
Action Siemens Medical Solutions USA, Inc., provided Customer Information Letter on 3/3/21 to affected customers via CT063/20/S. Customers with valid email addresses emailed a copy of the CSAN via Adobe Mega Sign. The CSAN will be distributed to the remaining customers address via hand delivery by the Siemens Customer Service Engineer. The letter states reason for recall, health risk and action to take: Siemens Healthineers has developed software update syngo.CT VA30A_SP3 to ensure uninterrupted scanning workflows and to reduce the number of user notifications. This update will also provide improvements related to the general system, examination and reconstruction processes, as well as improvements for dual energy post-processing. Following the corrective action, the cause has been eliminated and recurrence of the identified issues are prevented. This software update will be provided to you free of charge. How will the corrective action be implemented? Software update CT084/20/S will be performed onsite for SOMATOM X.cite (Model #11330001). For all other systems, the update CT064/20/S will be performed remotely. The remote software updates process will require approximately 180 minutes for completion. If you have any unresolved questions or you require technical support, please contact your local application specialists or your local service/sales organization at 1-800-888-7436.
Quantity in Commerce 190 units US
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 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 = JAK and Original Applicant = Siemens Medical Solutions USA, Inc.
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