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Siemens Medical Solutions USA, Inc Recall 89208

Description: SOMATOM Definition Edge -Computed tomography system Model 10590000

Siemens Medical Solutions USA, Inc Recall 89208 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0475-2022
Event ID89208
Event DescriptionSOMATOM Definition Edge -Computed tomography system Model 10590000
Product TypeDevices
DistributionUS Nationwide distribution.
Recall ReasonSoftware version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Device Classification20220119
Device Code InfoSerial 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
Center Classification Date20220110
Recall Initiation Date20211119
Recalling FirmSiemens Medical Solutions USA, Inc
Initial Notification Letter
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