Class 2 Device Recall Siemens

• Date Initiated by Firm: August 30, 2021
• Create Date: November 24, 2021
• Recall Status: Terminated on January 16, 2024
• Recall Number: Z-0285-2022
• Recall Event ID: 88888
• 510(K)Number: K190578
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
• Code Information: Serial Numbers: 155403 84012 83047 83095 83915 83801 155351 155353 83826 83754 83904 155521 83632 83743 155578 83931 83979 155393 155396 155413 155489 83238 83336 83984 83401 84006 83834 83562 155341 83564 83582 155606 83596 155596 155485 155437 83934 83746 83234 83971 155573 155335 155422 83332 155459 155382 83994 83026 83330 155501 155535 83281 83767 155600 83880 83683 155360 155361 155564 83339 155580 83244 155615 83585 83899 155504 155315 83852 83226 83271 83607 84011 155405 83403 83599 155373 83937 83246 83388 83668 155343 155554 155399 83837 83591 83878 83714 155463 155447 83574 83567 83832 83886 83662 83763 83308 155312 83871 83375 83988 83227 83359 83031 155364 83520 83262 155502 84019 83903 83901 155524 84024 155513 83798 83292 83083 83096 83243 83319 83294 83544 83637 83640 83705 83707 155354 155507 83581 83717 83056 83950 155559 83382 83819 83363 83307 155388 84020 83732 83752 155581 155584 155569 155427 83961 155329 83845 83236 155318 83348 155374 155365 83846 83399 155601 83749 83847 155322 83786 155300 83975 84016 155389 83914 83842 83775 83084 83004 155358 155443 155304 83014 83573 155515 83796 83274 94801 83768 83684 83552 83210 84001 83537 83233 83352 83569 155532 83711 83697 155572 83991 83395 155357 155356 155442 155582 155342 155530 83621 83859 83335 83278 83742 83018 83322 83392 155558 155350 83279 83276 83365 83970 83928 83015 83093 83327 83091 83946 83207 83938 155316 83230 83680 83945 155594 155621 155605 83291 155549 155328 83203 83214 83913 83896 155583 155614 83790 83875 155553 83232 83362 83824 83306 83542 84010 155384 155448 155506 155412 155493 83942 83941 84017 83981 155566 83257 155576 155495 83057 83539 83810 155579 83758 155497 83239 83398 83565 83313 83653 83957 83347 83349 84027 83323 83739 155369 83266 155510 83522 83898 83951 83387 155400 83733 155407 155371 83823 155434 155309 155386 155570 83611 83633 83985 155380 83967 83589
• 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: 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: 298 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