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U.S. Department of Health and Human Services

Class 2 Device Recall syngo.CT software

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  Class 2 Device Recall syngo.CT software see related information
Date Initiated by Firm July 25, 2019
Create Date August 30, 2019
Recall Status1 Terminated 3 on December 29, 2022
Recall Number Z-2440-2019
Recall Event ID 83519
510(K)Number K143401  K143400  K190578  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models:
SOMATOM Definition Edge-Model #10590000;
SOMATOM Definition AS Model #8098027;
SOMATOM Definition Flash Model #10430603
Code Information syngo.CT software version VA48A_SP5.5
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		 SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans
FDA Determined
Cause 2		 Software design
Action Siemens issued notification Urgent Medical Device Correction letter on 7/25/19 issued via electronic mail to consignees or by USPS certified mail if a consignee email address was not available. Letter states problem, health risk, action to take: The remote software update installation process will require approximately 30 minutes for completion. The process is completely automatic; make sure the system and power are stable before and during the process and do not switch off the system during the update process. Siemens highly recommends starting the installation when the scanner will not be in use or when the necessary time for the update to be completed can be scheduled. If your system is connected to Siemens Remote Connection, this update will be performed remotely. Following the corrective action, the cause will be eliminated and a recurrence of the identified issues is prevented. If you have any questions, please contact our service organization at 1-800-888-7436.
Quantity in Commerce 2867 units worldwide (OUS); 1464 units US
Distribution Nationwide Foreign:
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.
510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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