Class 2 Device Recall SOMATOM Definition AS

• Date Initiated by Firm: November 19, 2021
• Create Date: January 10, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0473-2022
• Recall Event ID: 89208
• 510(K)Number: K190578
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: SOMATOM Definition AS-Computed tomography system; Model 8098027
• Code Information: Serial Numbers: 96278 96887 66027 64492 64541 64519 64427 67297 95303 96267 64864 96211 59802 67241 64798 98423 65597 95389 96689 64419 64347 64860 64382 64869 65238 66734 92078 95804 96471 98402 95985 96710 95889 95778 92353 95847 95936 67236 64464 64471 65852 95798 96454 96466 95363 64927 91966 98354 95934 96279 95807 95602 95639 65288 64773 95229 65297 65159 64036 95628 66143 64317 95610 98474 95859 95939 95601 95070 95882 95596 95791 66219 65752 98356 95677 64104 66506 66312 95844 95670 66858 65382 98424 66588 92280 67399 64413 64559 64235 66611 92056 92261 92342 95684 66319 95545 96547 95702 95766 67218 67128 64859 95788 64487 96491 65370 95234 95466 95809 67098 95616 59819 66032 95372 95461 95043 66087 95582 95143 67363 96950 65768 92186 96941 95951 95100 98422 98413 66600 64030 66844 66649 66635 95299 66225 66842 66916 95584 95151 66188 66355 64022 92375 95578 96777 66467 98417 64498 64763 64372 95362 65788 65015 66150 96647 66933 96472 98366 65299 66461 66604 65115 66441 96948 95196 92184 92131 65515 66498 96380 96973 66197 66688 66164 95777 65769 95609 96424 96020 66768 65304 67233 95742 92298 64825 96413 96015 96824 65770 59825 67310 64066 66201 66406 66574 96529 95856 96544 65713 66700 65926 66503 98404 65443 96305 95881 95845 98364 96845 65804 95280 96773 96455 66126 65478 95923 95903 96747 67116 96726 95095 96370 98445 95940 64516 95784 98403 65407 65251 64720 92335 92300 66969 96750 96530 64685 66001 96038 96863 96992 95175 95457 95459 66928 65403 96341 66542 95465 92358 96984 67175 65740 66690 95451 67326 95274 95875 95983 67380 65555 64709 65291 66965 66151 67181 95891 64314 95181 66557 96633 96543 96669 66148 96335 95892 67288 67085 64446 92180 66705 96823 65418 95152 96421 67133 67048 95411 64677 67319 95960 64740 59820 98441 65755 66019 66062 92023 96014 96865 65501 66234 64221 98449 98357 95893 65927 65186 95659 59803 95193 98363 96709 96351 95413 64211 96385 95848 98359 96785 156012 66478 66850 96443 96749 92053 95437 96346 95272 64218 95207 64480 64947 95393 96893 96438 66999 95846 64463 65283 96369 95485 64835 64913 64834 64942 96316 96028 92243 66011 95647 67391 96812 66297 65818 96418 95344 92321 66618 96288 66396 96238 95080 96676 92101 96352 96444 92313 92177 96271 66473 66423 66304 66349 67010 67108 95438 95439 95751 95710 96336 96324 67229 65611 67126 65936 66958 65709 65556 92033 92296 96312 95906 96896 96021 92254 65735 95768 95715 91964 64489 64732 92169 98401 66183 65793 96937 95928 95968 98447 64051 95014 65728 96832 64282 95174 64031 66587 66789 64056 95425 67291 95415 64729 65235 64999 98411 66232 98350 66290 65229 96226 92132 65925 65148 95818 64060 95661 65455 64960 96340 66173 65145 64110 96929 66918 66808 96697 66843 92347 92307 65844 95339 95022 95748 95199 65779 96553 96303 65272 95646 95034 66021 66095 99401 96022 65151 96828 67312 96338 95302 64568 59828 65610 64248 96023 67169 67193 96545 64602 64707 66237 64096 98353 95952 65079 65831 92087 95868 96991 96942 92336 96899 64501 66308 95378 96266 65003 66792 95737 67274 96922 95912 65808 92207 92125 95361 65800 95961 95701 95376 96328 65557 65371 92315 66356 66381 96713 66821 95580 66812 64572 64967 65022 64052 65795 66221 67036 95427 65173 64407 65848 66930 66077 95782 95938 67251 95972 66116 95192 96851 65586 96250 96776 96347 96310 92058 64998 66457 66502 65154 66490 92088 95785 92099 92288 95522 64238 66110 59823 59829 64094 65659 66248 98473 66579 64796 64500 96425 95493 96061 96861 95593 64983 66931 66288 59824 98442 59822 96736 98414 95678 64247 66529 96541 92113 64322 95342 96983 64148 65760 65865 66265 66335 65854 95786 96524 65017 66813 96925 96909 98352 59812 96589 96440 98409 95592 66081 64924 64934 65701 66082 65909 64813 59814 96677 95221 95703 92108 65347 65392 92091 66925 95087 96717 92176 95517 98362 67232 96821 66076 66536 66041 64019 64767 66689 95441 66407 96857 95947 95484 65493 95521 95059 95359 65365 65803 65956 96837 64160 64605 64064 95021 95013 66023 95499 96967 64675 92189 96538 96668 66510 95924 95498 95147 98452 95808 66403 92409 91968 92000 66470 65680 65805 95575 96049 96040 95591 92323 66223 66540 96268 59815 67192 66630 95719 66280 95079 64908 65247 92057 95632 92208 92155 92165 96542 96740 66859 64297 95559 65995 67321 95797 95758 95145 96864 96281 66664 65667 96058 65157 96463 95440 95549 66434 66017 95577 96302 95523 66445 95674 65773 67083 156018 95642 95717 91996 92164 96053 66677 95520 96956 96011 95937 91974 66462 96327 96326 95402 96645 95025 96286 96700 96029 66882 91990 96604 95024 64196 65906 95927 96364 96397 67392 95886 65829 64712 64132 92045 65866 65743 65830 65694 65303 95195 92069 95640 98421 67167 95510 66771 95635 96695 65777 66860 66694 96062 65368 92098 95914 95657 65758 95513 66425 96275 96003 95529 98418 98419 64785 95716 65998 66447 65652 66959 UDI: UDI 04056869003665
• 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
• Quantity in Commerce: 794 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 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.