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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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  Class 2 Device Recall Siemens see related information
Date Initiated by Firm August 30, 2021
Create Date November 24, 2021
Recall Status1 Terminated 3 on January 16, 2024
Recall Number Z-0283-2022
Recall Event ID 88888
510(K)Number K190578  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM Force with software syngo.CT VB20
Model #10742326
Code Information Serial Numbers: 75708 75765 76356 76406 75550 75879 76211 76294 75714 75790 75709 76019 75949 76166 76175 76170 76156 76162 76169 75607 76186 94851 75984 75784 76397 76221 75789 76326 75617 75526 76199 75512 75775 75567 76298 76279 75536 75807 76379 76408 76231 76232 75711 75716 75514 76353 75875 75899 75770 76152 75600 76357 75994 75563 76046 76089 75794 76366 76374 76193 75974 76059 76196 75897 76241 75510 76274 76292 76343 75892 75792 75535 75820 75754 75755 75993 75916 75971 75893 75944 75923 75540 76027 76362 76454 75739 75980 76217 76091 76101 75571 75848 76329 75818 76138 75850 75973 75437 75500 75527 75953 75885 76074 76385 75728 76142 76205 76064 76337 76090 76405 75939 75475 76147 75877 75727 76163 76057 75481 75439 75776 75450 75482 76237 75760 76403 75710 76056 76080 76118 75806 75808 76114 75588 75476 75931 76228 75890 76320 76203 75493 75900 76387 75528 75467 75823 76332 76334 75454 76003 75761 76207 75814 76416 75906 76097 75602 75487 76248 75837 75787 75743 75793 76010 76061 76202 76208 76441 75478 76415 76041 75936 75959 76275 75905 76293 76440 75942 75941 75604 75805 75513 76377 75884 76439 76006 75867 75532 75919 76140 76050 75913 76190 76181 76424 75843 76016 75983 75460 75555 76418 76368 76168 75524 75778 75515 76411 75610 75559 75501 75570 75769 76189 75774 76280 75849 76236 75788 76000 76073 75752 75999 75976 76008 75616 75750 76258 75576 75845 75852 75605 76001
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		 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur
FDA Determined
Cause 2		 Software design
Action Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice (CSAN) to customers via CT021/21/S on 8/30/2021. The CSAN informs the customer of the issues health risk, the new software update version VB20_SP5 to eliminate the root causes of these problems. The software update will be distributed free of charge via CT020/21/S and CT071/21/S (update is dependent on the current software version) to all affected customers. Action to take: Siemens Healthineers has developed software update syngo.CT VB20 SP5. This new software contains workflow improvements and solutions to the previously described software issues. Please ask your local service organization if you are interested in more detailed information about the content of the software update. The new software, VB20_SP5, will be provided free of charge and will be distributed via Update CT020/21/S or CT071/20/S. Update CT071/20/S is only necessary if the system is being updated from software version VB20, VB20_SP1, or VB20_SP2 directly to VB20_SP5. Following the corrective action process CAPA, the cause of identified product issues has been eliminated and a recurrence of the identified issues is prevented. This update will be performed remotely. The remote software updates process will require approximately 45 minutes for completion and is completely automatic; however, please make sure the system and power are stable before and during the process, please 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 you have any questions, please contact our service organization at at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein
Quantity in Commerce 232 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 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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