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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens SOMATOM Family

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  Class 2 Device Recall Siemens SOMATOM Family see related information
Date Initiated by Firm March 07, 2022
Create Date April 20, 2022
Recall Status1 Open3, Classified
Recall Number Z-0962-2022
Recall Event ID 89901
510(K)Number K163296  K173632  K192061  K200524  K211373  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SIEMENS SOMATOM with software syngo CT VA30A_SP4
Models:
SOMATOM go.Now 11061610 & 11061618
SOMATOM go.Up 11061620 & 11061628
SOMATOM go.All 11061630 & 11061638
SOMATOM go.Top 11061640 & 11061648
SOMATOM go.Sim 11061660 & 11061668
SOMATOM go.Open Pro 11061670 & 11061678
SOMATOM X.cite 11330001
Intended Use: Computed tomography x-ray system
Code Information Software syngo CT VA30A_SP4 Serial numbers: 106115 106133 106237 106260 106360 106400 106459 106464 106484 106526 106527 106545 106562 108054 108056 108062 108076 108080 108085 108088 108095 108099 108101 108106 108108 108109 108111 108112 108113 108114 108116 108117 108118 108120 108125 108126 108128 108133 108146 108154 108158 108163 108168 108170 108174 108175 108176 108177 108178 108183 111219 111230 111232 111233 111236 111237 111249 111250 111266 111271 111273 111277 111281 111286 111289 111293 111297 111299 111302 111306 111308 111310 111313 111315 111317 111319 111323 111328 111339 111341 111345 111350 111351 111352 111355 111366 111367 111368 111369 111370 111371 111373 111378 111379 111381 111383 111386 111391 111394 111397 111398 111409 111413 111415 111416 111417 111420 111421 111426 111427 111428 111437 111438 111440 111441 111445 111446 111450 111452 111453 111454 111458 111460 111463 111465 111466 111469 111477 111485 111490 111491 111503 111504 111507 111510 111511 111514 111515 111523 111525 111532 111539 111542 111546 111550 111560 111562 111564 111578 111580 111582 111586 111587 111590 111617 111634 111644 111653 111703 111712 111717 111718 111726 111754 111757 111770 111773 111780 111794 111805 111814 111815 111824 111837 111862 111901 111904 111907 111927 111940 111965 111973 111974 111980 111981 111985 111986 111989 112000 112008 112013 112023 112030 112031 112035 112040 112045 112057 112059 112060 112061 112070 112071 112074 112077 112086 112088 112101 112103 112105 112112 112118 112139 112140 112149 112156 112157 112159 112166 112173 112179 112180 112182 112190 112518 112519 112541 112542 112545 112551 112552 112555 112573 112574 112577 112578 112579 112588 112591 112598 112610 112614 112632 112682 112705 112744 112765 112773 112779 112786 112861 117479 117482 117483 117484 117492 117495 117505 117508 117510 117515 117516 117520 117521 117522 117523 117529 117547 117557 117558 117560 117567 117570 117577 117582 117583 117586 117592 117600 117602 117605 117610 117611 117612 117615 117622 117623 117626 117633 117636 117637 117642 117644 117646 117648 117657 117674 117686 117692 117693 117708 117730 117732 117734 117739 117745 117750 117757 117774 117778 117780 117782 117784 117785 117787 117789 117794 117795 117800 117802 117813 117817 117824 117833 117834 117838 117849 117857 117858 117862 117865 117878 117880 117885 117889 117896 118151 119081 119083 119084 119085 119086 119087 119088 119090 119093 119098 119111 119115 119120 119122 119123 119125 119132 119133 119141 119143 119144 119145 119148 119152 119153 119157 119158 119173 119178 119180 119181 119190 119192 119197 119198 119200 119201 119208 119209 119213 119214 119217 119220 119227 119231 119234 119235 119237 119238 119239 119243 119254 119259 119261 119263 119264 119268 119271 119284 119290 119301 119317 119318 119319 119328 119330 119339 119346 119361 119386 119387 119388 119389 119400 119409 119410 119412 119419 119429 119435 119437 119439 119451 119471 119472 119475 119480 119482 119484 119485 119491 119500 119501 119512 119528 119540 119544 119548 119562 119574 119580 119582 119599 119616 119622 119623 119630 119631 119633 119634 119637 119639 119646 119661 119663 119671 119679 119694 119722 119724 119739 119740 119745 119749 119751 119752 119754 119761 119764 119769 119770 119773 119776 119778 119780 119781 119786 119794 119795 119805 119806 119828 119841 119866 119870 119871 119876 119877 119878 119884 119887 119891 119895 119913 123054 123055 123059 123060 123069 123104 123118 123122 123129 123130 128015 128016 128029 128035 128039 128041 128046 128049 128051 128057 128063 128068 128075 128085 128086 128088 128097 128098 128099 128100 128101 128102 130012 130015 130021 130022 130036 130039 130044 130048 130052 130054 130057 130059 130061 130063 130065 168108 168163 172508 172512 172518 172520 172532 172537 172550 UDI: SOMATOM go.Now 04056869051291 & 04056869051307 SOMATOM go.Up 04056869051314 & 04056869051321 SOMATOM go.All 04056869151564 & 04056869151588 SOMATOM go.Top 04056869151571 & 04056869151595 SOMATOM go.Sim 04056869249230 & 04056869239736 SOMATOM go.Open Pro 04056869249247 & 04056869239743 SOMATOM X.cite 04056869231044
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 error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan
FDA Determined
Cause 2		 Software design
Action Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to customers via CT010/22/S via email/mail on March 7, 2022. Letter states reason for recall, health risk and action to take: There are no workarounds for these issues. Customers are urged to install the remote update as soon as it is released. How will the corrective action be implemented and what is the efficiency of the corrective actions? Siemens has developed software update syngo CT VA30A_SP5 to ensure more stable scanning workflows, reduce the number of user notifications, and to further improve the image quality and reduce image artifacts. This update will provide workflow improvements, bug fixes for performance and stability problems observed in installed base. Corrective action will be provided free of charge and will be remotely distributed via Update Instruction CT008/22/S or CT088/21/S (X.cite only). The remote software update process will require approximately 180 minutes for completion. If you have any technical or scheduling questions, please contact our service organization 1-800-888-7436. You may also reach to the Regional Unit Contact listed on the first page of this notification. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Acknowledge Receipt of this Safety Advisory Notice 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 understood the content therein. Please include your Siemens system names, material numbers, serial numbers, and Siemens Functional Location numbers and email this information to: recallsandrefusals.team@siemens-healthineers.com. Additionally, a software solution (VA30A_SP5) to eliminate the root cause of this problem is being distributed via CT008/22/S or CT088/21/S (X.cite only) to all affected customers free of charge. Fol
Quantity in Commerce 547 units US
Distribution Nationwide
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.
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