Events

Device Recall 4D Integrated Treatment Console 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems, Inc. Oncology Systems 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    59586
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3194-2011
  • 사례 시작날짜
    2011-07-21
  • 사례 출판 날짜
    2011-09-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103151
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Accelerator, linear, medical - Product Code IYE
  • 원인
    The 4d integrated treatment console may erratically fail to load the planned physical wedge accessory without warning or notification when receiving an approved plan from the oncology information system.
  • 조치
    Urgent Medical Device Correction/Field Safety Notification letters were sent to all US consignees by Certified Mail on July 21, 2011., as well as Varian Sales, Marketing and Service Organizations. Varian International Customer Support managers will notify international customers by appropriate methods. The letter informed customers of the issue and the corrective action steps. Letters request that all appropriate personnel working in the radiotherapy department be notified of the contents of the letter. A new release version is being created to correct the issue. All sites will be notified when it is available. Questions or concerns should be directed to 1-888-827-4265. Contact information for international customers is also provided as well as a list of all affected serial numbers.

Device

Device Recall 4D Integrated Treatment Console
  • 모델명 / 제조번호(시리얼번호)
    Model No. H51: Code numbers:  H510010 H512265 H513062 H513649 H514050 H514275 H514422 H514585 H514750 H514905 H515065 H515154 H515261 H510175 H512273 H513078 H513663 H514051 H514277 H514436 H514586 H514752 H514907 H515067 H515156 H515262 H510273 H512278 H513080 H513674 H514053 H514280 H514437 H514590 H514754 H514908 H515068 H515158 H515263 H510280 H512298 H513089 H513690 H514064 H514283 H514440 H514592 H514756 H514910 H515070 H515161 H515264 H510283 H512341 H513092 H513691 H514076 H514285 H514441 H514600 H514758 H514911 H515071 H515163 H515266 H510435 H512357 H513104 H513693 H514079 H514288 H514449 H514601 H514759 H514912 H515072 H515164 H515267 H510600 H512366 H513112 H513697 H514082 H514289 H514456 H514602 H514763 H514913 H515075 H515167 H515270 H510646 H512396 H513174 H513699 H514083 H514291 H514457 H514603 H514768 H514915 H515076 H515169 H515271 H510648 H512398 H513181 H513704 H514084 H514296 H514460 H514604 H514769 H514916 H515077 H515171 H515273 H510665 H512436 H513184 H513707 H514085 H514297 H514461 H514605 H514770 H514917 H515078 H515173 H515275 H510702 H512437 H513185 H513709 H514086 H514300 H514462 H514607 H514778 H514919 H515079 H515174 H515278 H510783 H512454 H513188 H513714 H514098 H514301 H514466 H514608 H514779 H514920 H515080 H515175 H515284 H510794 H512464 H513208 H513715 H514100 H514303 H514467 H514611 H514781 H514922 H515082 H515176 H515285 H510846 H512475 H513210 H513716 H514112 H514304 H514468 H514612 H514782 H514924 H515083 H515178 H515286 H510983 H512509 H513231 H513717 H514114 H514305 H514469 H514613 H514783 H514929 H515085 H515179 H515289 H511003 H512513 H513241 H513733 H514115 H514306 H514471 H514615 H514787 H514934 H515086 H515180 H515291 H511036 H512522 H513249 H513748 H514122 H514307 H514474 H514618 H514788 H514937 H515087 H515182 H515292 H511114 H512532 H513253 H513759 H514123 H514310 H514478 H514619 H514789 H514940 H515088 H515183 H515294 H511176 H512555 H513256 H513761 H514125 H514311 H514481 H514623 H514792 H514942 H515089 H515184 H515298 H511208 H512560 H513265 H513763 H514144 H514316 H514482 H514624 H514793 H514944 H515090 H515188 H515302 H511213 H512568 H513266 H513770 H514147 H514319 H514485 H514625 H514794 H514949 H515091 H515190 H515303 H511246 H512607 H513281 H513773 H514152 H514320 H514487 H514628 H514795 H514951 H515092 H515191 H515304 H511247 H512613 H513289 H513775 H514153 H514326 H514488 H514631 H514796 H514962 H515094 H515192 H515306 H511261 H512618 H513299 H513780 H514155 H514330 H514489 H514632 H514798 H514963 H515099 H515194 H515310 H511276 H512620 H513307 H513789 H514156 H514332 H514490 H514633 H514801 H514967 H515100 H515196 H515314 H511320 H512637 H513314 H513795 H514161 H514336 H514491 H514636 H514804 H514968 H515101 H515197 H515315 H511393 H512643 H513322 H513829 H514164 H514342 H514494 H514638 H514805 H514970 H515102 H515198 H515317 H511399 H512658 H513339 H513831 H514171 H514343 H514497 H514640 H514811 H514971 H515105 H515200 H515318 H511402 H512676 H513353 H513837 H514179 H514344 H514498 H514641 H514812 H514975 H515106 H515201 H515319 H511474 H512677 H513356 H513838 H514184 H514351 H514501 H514643 H514814 H514976 H515107 H515205 H515320 H511489 H512678 H513372 H513862 H514185 H514352 H514507 H514644 H514815 H514980 H515108 H515207 H515321 H511507 H512679 H513379 H513863 H514186 H514355 H514508 H514647 H514817 H514981 H515110 H515209 H515322 H511518 H512687 H513400 H513866 H514191 H514359 H514516 H514648 H514820 H514982 H515112 H515210 H515325 H511563 H512693 H513407 H513869 H514193 H514362 H514517 H514651 H514821 H514983 H515113 H515211 H515328 H511636 H512694 H513441 H513871 H514198 H514364 H514518 H514652 H514824 H514993 H515115 H515212 H515329 H511663 H512710 H513452 H513876 H514201 H514365 H514522 H514654 H514826 H514995 H515116 H515213 H515330 H511679 H512711 H513456 H513877 H514202 H514367 H514529 H514660 H514827 H515005 H515117 H515214 H515336 H511683 H512712 H513462 H513880 H514204 H514374 H514530 H514663 H514828 H515006 H515118 H515220 H515337 H511701 H512716 H513470 H513888 H514208 H514375 H514541 H514664 H514829 H515007 H515121 H515224 H515340 H511724 H512737 H513471 H513892 H514211 H514376 H514544 H514667 H514830 H515009 H515122 H515225 H515341 H511764 H512812 H513477 H513919 H514213 H514378 H514546 H514668 H514832 H515011 H515123 H515227 H515345 H511768 H512835 H513495 H513929 H514220 H514380 H514547 H514670 H514834 H515012 H515125 H515229 H515346 H511771 H512847 H513496 H513930 H514223 H514386 H514551 H514673 H514843 H515021 H515127 H515231 H515350 H511823 H512856 H513498 H513932 H514224 H514391 H514554 H514675 H514849 H515026 H515129 H515232 H515351 H511846 H512863 H513510 H513939 H514225 H514393 H514556 H514682 H514851 H515033 H515131 H515236 H515353 H511864 H512889 H513520 H513942 H514226 H514394 H514559 H514685 H514852 H515038 H515132 H515238 H515354 H511931 H512938 H513521 H513944 H514228 H514395 H514562 H514688 H514854 H515039 H515134 H515240 H515358 H511961 H512940 H513523 H513957 H514230 H514396 H514564 H514691 H514855 H515043 H515135 H515242 H515360 H511964 H512956 H513527 H513959 H514231 H514398 H514565 H514692 H514856 H515045 H515141 H515244 H515361 H511982 H512959 H513528 H513962 H514232 H514400 H514568 H514702 H514857 H515046 H515142 H515246 H515362 H512003 H512962 H513539 H513968 H514249 H514401 H514570 H514703 H514862 H515048 H515143 H515248 H515365 H512012 H512978 H513546 H513980 H514257 H514407 H514572 H514708 H514863 H515050 H515144 H515249 H515366 H512029 H512980 H513547 H513982 H514258 H514408 H514574 H514711 H514875 H515055 H515145 H515250 H515369 H512097 H512987 H513549 H513995 H514262 H514410 H514575 H514716 H514876 H515056 H515147 H515251 H515370 H512120 H512989 H513561 H514006 H514269 H514411 H514577 H514722 H514880 H515059 H515148 H515253 H515371 H512131 H512990 H513575 H514008 H514270 H514412 H514578 H514723 H514881 H515060 H515150 H515257 H515373 H512163 H512998 H513600 H514009 H514272 H514416 H514579 H514724 H514890 H515061 H515151 H515258 H515376 H512184 H513011 H513626 H514022 H514273 H514417 H514580 H514735 H514898 H515062 H515152 H515259 H515377 H512226 H513045 H513648 H514032 H514274 H514420 H514581 H514736 H514899 H515063 H515153 H515260 H515379      H515380 H515502 H515630 H515753 H515894 H518106 H515381 H515504 H515632 H515755 H515895 H518107 H515382 H515505 H515633 H515756 H515896 H518116 H515384 H515506 H515638 H515757 H515897 H518117 H515385 H515507 H515641 H515758 H515898 H518120 H515387 H515510 H515642 H515761 H515900 H518122 H515392 H515513 H515643 H515765 H515901 H518128 H515394 H515514 H515644 H515767 H515902 H518129 H515397 H515515 H515646 H515771 H515903 H518130 H515398 H515516 H515648 H515774 H515904 H518131 H515400 H515518 H515650 H515776 H515906 H518132 H515401 H515522 H515658 H515777 H515907 H518136 H515405 H515527 H515663 H515778 H515908 H518139 H515406 H515528 H515664 H515782 H515912 H518145 H515408 H515530 H515666 H515784 H515914 H518150 H515409 H515531 H515667 H515785 H515915 H518152 H515410 H515532 H515669 H515789 H515917 H518153 H515412 H515533 H515670 H515796 H515918 H518154 H515414 H515534 H515673 H515797 H515920 H518156 H515415 H515535 H515674 H515798 H515924 H518157 H515417 H515536 H515676 H515800 H515925 H518161 H515418 H515541 H515679 H515801 H515926 H518164 H515419 H515543 H515680 H515802 H515929 H518170 H515420 H515545 H515681 H515805 H515932 H518171 H515421 H515552 H515685 H515809 H515934 H518172 H515422 H515553 H515686 H515810 H515936 H518173 H515427 H515554 H515687 H515811 H515937 H518182 H515430 H515560 H515690 H515812 H515942 H518185 H515431 H515561 H515694 H515813 H515946 H518186 H515432 H515562 H515695 H515818 H515947 H518187 H515433 H515563 H515699 H515819 H515948 H518188 H515435 H515566 H515700 H515820 H515951 H518189 H515436 H515567 H515701 H515825 H515960 H518192 H515439 H515568 H515702 H515827 H515961 H518200 H515442 H515570 H515703 H515828 H515962 H51A001 H515445 H515578 H515705 H515831 H515963 H51A002 H515446 H515579 H515706 H515833 H515964 H51B002 H515447 H515581 H515707 H515837 H515965 H51B003 H515452 H515585 H515711 H515839 H515974 H51B004 H515454 H515587 H515712 H515840 H515975 H51B005 H515455 H515589 H515713 H515841 H515976 H51B006 H515456 H515591 H515714 H515842 H515979 H51B008 H515460 H515595 H515715 H515846 H515980 H51B012 H515461 H515596 H515716 H515847 H515981 H51B014 H515462 H515597 H515718 H515848 H515983 H51B016 H515464 H515598 H515723 H515850 H515984 H51B020 H515465 H515599 H515724 H515856 H515985 H51B028 H515472 H515601 H515728 H515857 H515989 H51B031 H515474 H515604 H515730 H515861 H515991 H51B032 H515475 H515607 H515731 H515874 H515992 H51B035 H515476 H515610 H515734 H515875 H515993 H51B036 H515477 H515613 H515736 H515877 H515997 H51B043 H515478 H515615 H515740 H515878 H515998 H51B045 H515480 H515619 H515741 H515880 H515999  H515484 H515620 H515742 H515882 H517058  H515485 H515621 H515743 H515884 H517059  H515490 H515623 H515746 H515888 H517241  H515491 H515624 H515747 H515889 H517545  H515492 H515625 H515748 H515890 H517567  H515494 H515626 H515749 H515891 H517892  H515500 H515628 H515751 H515892 H518104
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, China, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Guadeloupe, Ireland, Italy, Latvia, Lithuania, Martinique, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Turkey, United Kingdom, Singapore, Algeria, Bangladesh, Belarus, Egypt, Guam, Hong Kong, India, Indonesia, Iraq, Israel, Kenya, Kuwait, Macau, Malaysia, Philippines, Qatar, Russia, South Africa, South Korea; Taiwan, Thailand, Tunisia, Ukraine, United Arab Emirates, Japan, Brazil, Chile, Columbia, Dominican Republic, Ecuador, Mexico, Peru, Venezuela, New Zealand, and Australia.
  • 제품 설명
    4D Integrated Treatment Console v 8.6 with ARIA RT Chart v8.5, all of 4DITC v 8.3; || Varian Medical Systems, Palo Alto, CA || Designed to assist the operator of a radiation therapy device in providing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • 제조사 주소
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • 제조사 모회사 (2017)
    Varian Medical Systems Inc
  • Source
    USFDA