Class 2 Device Recall SOMATOM Definition Edge

• Date Initiated by Firm: November 19, 2021
• Create Date: January 10, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0475-2022
• Recall Event ID: 89208
• 510(K)Number: K190578
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: SOMATOM Definition Edge -Computed tomography system; Model 10590000
• Code Information: Serial Numbers: 155403 84012 83047 83095 83915 83801 155351 155658 155353 83826 83754 83277 83249 83904 155521 83632 83743 155578 83931 83979 155393 155396 155413 155489 83238 83336 83984 83401 84006 83834 155671 155649 83562 155341 83564 155613 83582 155606 83596 155596 155485 155437 83934 83746 83234 83971 155573 155335 83321 155422 83332 155459 155382 83994 83026 83330 155501 155639 155535 83281 83558 83767 155600 83880 83683 155360 155361 155564 83339 155580 83244 155615 83585 83899 155504 155315 155592 83613 83852 83226 83271 83607 84011 155405 83403 83599 155373 83695 83937 83246 83388 83668 155642 155343 155554 155399 83584 83837 83591 155616 83878 83714 155463 155447 155630 83574 155318 83567 83832 83886 83662 83763 83308 155312 155557 83871 83375 83988 155629 155637 83227 83359 83031 155364 83520 83262 155502 155627 84019 83903 83901 155524 84024 155513 83798 83292 83243 83319 83294 83544 83637 83640 83705 83083 83096 83707 155354 155507 83581 83717 155634 155632 83728 83056 83950 155559 83382 83819 83041 83363 83307 155388 84020 83732 83752 155581 155584 155569 155427 83961 155329 83845 83236 83348 155374 155365 83846 83399 155601 83749 83847 155322 83786 155300 155636 83975 84016 155389 83914 83842 83775 83084 83004 155358 155623 83669 155443 155304 83014 83573 155655 155515 83796 83274 94801 83768 155575 83684 83552 83210 84001 83537 83233 83352 83569 83909 155532 83968 155348 155585 83711 83697 155572 83991 155668 83395 155356 155357 155660 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 83254 83680 83708 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 155638 83823 155434 155309 155653 155386 155570 83611 83633 83985 155380 83967 83589 UDI: UDI 04056869006949
• 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 version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
• FDA Determined Cause: Software Design Change
• Action: Siemens issued Urgent Medical Device Correction letter CSAN CT067/21/S on November 19, 2021, to notify affected customers of the head image degradation issue and to provide them with a workaround solution. Letter states reason for recall, health risk and action to take: To avoid potential misdiagnosis, it is mandatory to change to the new cupping correction setting CC = 4 immediately, restart the application, and (if applicable) reconstruct the raw data again. Cupping correction setting CC = 4 is a further development of CC = 1: The Image impression is very similar to setting CC = 1 but an important improvement reduces possible artifacts. For customers who have routinely been using CC = 0 and CC = 2 instead of CC = 1, the image impression with CC = 4 will be different from what they are used to. Please note that the use of cupping correction CC = 4 may cause slightly altered CT numbers of non-water equivalent body materials or tissues in reconstructions with H-kernels and enabled iBHC (i.e., setting Bone or Iodine ) compared to results obtained with settings CC = 0, 1, or 2. For any quantitative interpretation of CT numbers, e.g., the mapping of HU to electron density, a recalibration is necessary Siemens is developing a technical solution, VB20_SP6 with high priority .Siemens Healthineers is working with high priority on a solution for the described degradation. The solution will be provided with software version VB20_SP6. Your local service organization will contact you in due time and schedule an appropriate date for the installation of the solution. This solution will be provided to you free of charge. Please note that the Regional Unit Contact cannot schedule your appointment. If you have any unresolved questions or require technical support, please contact your local applicable specialist or our service organization at 1-800-888-7436. Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the informati
• 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 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) Database: 510(K)s with Product Code = JAK and Original Applicant = Siemens Medical Solutions USA Inc.