Events

Device Recall Varian brand CSeries Ximatron Radiotherapy Treatment Stimulator, 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems 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
    56350
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0892-2011
  • 사례 시작날짜
    2010-01-19
  • 사례 출판 날짜
    2011-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93282
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
  • 원인
    There is a potential for failure of a lead screw drive system or image intensifier lead screw drive assembly, if normal maintenance inspections are not followed correctly.
  • 조치
    Varian sent an URGENT MEDICAL DEVICE CORRECTION letter via certified mail receipt on January 19, 2010, to all direct consignees. The letter identified the product, the problem, and the action the consignee should take. Consignees were instructed to have maintenance personnel perform the recommended measurements as described in the Varian Customer Technical Bulletin. Ensure that all measurements made as part of the procedure are recorded in the 'wear table' that is part of the procedure. Previous wear measurements should be compared to new measurements and any large increase in wear should be investigated immediately. Pay special attention to the "Recommendations based on wear measurements" table. Ensure that new wear measurements comply with the operating parameters described in the table. For any questions consignees are to contact Varian Medical Systems Customer Support Services at one of the locations described in the CTB. For questions regarding this recall call (650) 424-5731.

Device

Device Recall Varian brand CSeries Ximatron Radiotherapy Treatment Stimulator,
  • 모델명 / 제조번호(시리얼번호)
    Listed are the affected system Serial Numbers. The last four digits represent the serial number of the device.  H720003 ,H720119 ,H720209 ,H720270 ,H720347 ,H720416 ,H720491 ,H720557 ,H720618, H720006 ,H720122 ,H720210 ,H720271 ,H720348 ,H720417 ,H720495 ,H720558 ,H720620, H720009 ,H720123 ,H720211 ,H720273 ,H720350 ,H720419 ,H720496 ,H720559 ,H720622, H720013 ,H720124 ,H720213 ,H720274 ,H720351 ,H720422 ,H720498 ,H720560 ,H720624, H720015 ,H720125 ,H720215 ,H720276 ,H720352 ,H720424 ,H720499 ,H720561 ,H720626, H720017 ,H720129 ,H720217 ,H720279 ,H720353 ,H720425 ,H720500 ,H720562 ,H720627, H720021 ,H720132 ,H720218 ,H720280 ,H720354 ,H720427 ,H720501 ,H720563 ,H720628, H720022 ,H720133 ,H720219 ,H720281 ,H720355 ,H720429 ,H720502 ,H720565 ,H720629, H720025 ,H720134 ,H720221 ,H720282 ,H720357 ,H720432 ,H720503 ,H720566 ,H720632, H720035 ,H720137 ,H720222 ,H720283 ,H720358 ,H720435 ,H720505 ,H720567 ,H720637, H720037 ,H720138 ,H720225 ,H720284 ,H720362 ,H720437 ,H720506 ,H720568 ,H720638, H720040 ,H720140 ,H720229 ,H720288 ,H720363 ,H720438 ,H720508 ,H720571 ,H720639, H720041 ,H720143 ,H720230 ,H720289 ,H720367 ,H720439 ,H720509 ,H720572 ,H720641, H720048 ,H720144 ,H720231 ,H720290 ,H720373 ,H720440 ,H720511 ,H720573 ,H720642, H720051 ,H720145 ,H720232 ,H720292 ,H720374 ,H720442 ,H720513 ,H720575 ,H720643, H720052 ,H720148 ,H720233 ,H720293 ,H720375 ,H720443 ,H720514 ,H720577 ,H720644, H720056 ,H720152 ,H720234 ,H720294 ,H720376 ,H720445 ,H720515 ,H720578 ,H720647, H720057 ,H720154 ,H720235 ,H720295 ,H720379 ,H720447 ,H720516 ,H720579 ,H720648, H720059 ,H720157 ,H720236 ,H720296 ,H720383 ,H720449 ,H720518 ,H720584 ,H720650, H720060 ,H720159 ,H720237 ,H720297 ,H720384 ,H720452 ,H720522 ,H720585 ,H720651, H720064 ,H720164 ,H720239 ,H720298 ,H720386 ,H720457 ,H720523 ,H720586 ,H720653, H720069 ,H720165 ,H720241 ,H720299 ,H720388 ,H720458 ,H720525 ,H720588 ,H720654, H720070 ,H720167 ,H720242 ,H720300 ,H720391 ,H720461 ,H720526 ,H720589 ,H720659, H720071 ,H720168 ,H720245 ,H720303 ,H720392 ,H720465 ,H720528 ,H720590 ,H720660, H720072 ,H720169 ,H720247 ,H720307 ,H720394 ,H720466 ,H720530 ,H720591 ,H720661, H720074 ,H720177 ,H720248 ,H720309 ,H720395 ,H720470 ,H720531 ,H720592 ,H720663, H720075 ,H720180 ,H720251 ,H720316 ,H720396 ,H720471 ,H720533 ,H720594 ,H720664, H720082 ,H720181 ,H720254 ,H720320 ,H720397 ,H720472 ,H720534 ,H720595 ,H720666, H720083 ,H720182 ,H720255 ,H720327 ,H720399 ,H720477 ,H720536 ,H720596 ,H720667, H720088 ,H720183 ,H720256 ,H720328 ,H720402 ,H720478 ,H720537 ,H720597 ,H720668, H720089 ,H720185 ,H720257 ,H720329 ,H720403 ,H720479 ,H720539 ,H720598 ,H720669, H720092 ,H720186 ,H720258 ,H720330 ,H720404 ,H720481 ,H720546 ,H720599 ,H720670, H720098 ,H720187 ,H720261 ,H720336 ,H720405 ,H720482 ,H720547 ,H720600 ,H720671, H720101 ,H720188 ,H720262 ,H720337 ,H720406 ,H720484 ,H720548 ,H720601 ,H720672, H720106 ,H720195 ,H720263 ,H720338 ,H720407 ,H720485 ,H720550 ,H720604 ,H720673, H720107 ,H720196 ,H720264 ,H720339 ,H720409 ,H720486 ,H720553 ,H720605 ,H720674, H720108 ,H720199 ,H720265 ,H720344 ,H720411 ,H720487 ,H720554 ,H720608 ,H720675, H720112 ,H720200 ,H720266 ,H720345 ,H720414 ,H720488 ,H720555 ,H720615 ,H720676, H720113 ,H720204 ,H720269 ,H720346 ,H720415 ,H720489 ,H720556 ,H720616 ,H720678,   H720679 ,H720743 ,H720805 ,H720858 ,H720905 ,H720955 ,H721005, H720680 ,H720744 ,H720806 ,H720859 ,H720906 ,H720956 ,H721006, H720681 ,H720746 ,H720807 ,H720860 ,H720907 ,H720957 ,H721007, H720682 ,H720747 ,H720808 ,H720861 ,H720908 ,H720958 ,H721008, H720683 ,H720748 ,H720809 ,H720862 ,H720909 ,H720959 ,H721009, H720684 ,H720749 ,H720810 ,H720863 ,H720910 ,H720960 ,H721010, H720686 ,H720750 ,H720811 ,H720864 ,H720911 ,H720961 ,H721011, H720688 ,H720752 ,H720812 ,H720865 ,H720913 ,H720962 ,H721012, H720689 ,H720754 ,H720813 ,H720866 ,H720914 ,H720963 ,H721013, H720692 ,H720756 ,H720814 ,H720867 ,H720915 ,H720964 ,H721014, H720693 ,H720759 ,H720815 ,H720868 ,H720916 ,H720965 ,H721015, H720694 ,H720760 ,H720816 ,H720869 ,H720918 ,H720966 ,H721016, H720697 ,H720761 ,H720817 ,H720870 ,H720919 ,H720967 ,H721017, H720699 ,H720763 ,H720818 ,H720871 ,H720920 ,H720968 ,H721018, H720701 ,H720766 ,H720819 ,H720872 ,H720921 ,H720969 ,H721019, H720702 ,H720767 ,H720820 ,H720873 ,H720922 ,H720974 ,H721020, H720704 ,H720769 ,H720822 ,H720874 ,H720923 ,H720975 ,H721022, H720705 ,H720770 ,H720823 ,H720875 ,H720925 ,H720976 ,H721023, H720706 ,H720773 ,H720824 ,H720876 ,H720926 ,H720977 ,H721024, H720707 ,H720774 ,H720825 ,H720877 ,H720927 ,H720978 ,H721025, H720711 ,H720775 ,H720826 ,H720878 ,H720928 ,H720979 ,H721026, H720712 ,H720776 ,H720827 ,H720879 ,H720929 ,H720980 ,H721027, H720714 ,H720777 ,H720829 ,H720880 ,H720930 ,H720981 ,H721028, H720715 ,H720778 ,H720830 ,H720881 ,H720931 ,H720982 ,H721029, H720716 ,H720780 ,H720831 ,H720882 ,H720932 ,H720983 ,H721030, H720718 ,H720781 ,H720832 ,H720883 ,H720933 ,H720984 ,H721031, H720719 ,H720782 ,H720833 ,H720884 ,H720935 ,H720985 ,H721032, H720720 ,H720783 ,H720834 ,H720885 ,H720936 ,H720986 ,H721033, H720721 ,H720784 ,H720835 ,H720886 ,H720937 ,H720987 ,H721034, H720722 ,H720786 ,H720836 ,H720888 ,H720938 ,H720988 ,H721035, H720723 ,H720787 ,H720840 ,H720889 ,H720940 ,H720989 ,H721036, H720724 ,H720788 ,H720841 ,H720890 ,H720941 ,H720990 ,H721037, H720725 ,H720790 ,H720842 ,H720891 ,H720942 ,H720991 ,H721038, H720726 ,H720792 ,H720843 ,H720892 ,H720943 ,H720992 ,H721039, H720727 ,H720795 ,H720844 ,H720894 ,H720945 ,H720993 ,H721040, H720728 ,H720796 ,H720847 ,H720895 ,H720946 ,H720995 ,H721041, H720729 ,H720797 ,H720848 ,H720896 ,H720947 ,H720996 ,H721042, H720732 ,H720798 ,H720849 ,H720897 ,H720948 ,H720997 ,H721043, H720733 ,H720799 ,H720851 ,H720898 ,H720949 ,H720998 ,H721044, H720734 ,H720800 ,H720852 ,H720899 ,H720950 ,H720999 ,H721045, H720737 ,H720801 ,H720854 ,H720901 ,H720951 ,H721000 ,H721046, H720739 ,H720802 ,H720855 ,H720902 ,H720952 ,H721001 ,H721047, H720741 ,H720803 ,H720856 ,H720903 ,H720953 ,H721002 ,H721048, H720742 ,H720804 ,H720857 ,H720904 ,H720954 ,H721004
  • 의료기기 분류등급
    Radiology Devices
  • 유통
    Worldwide Distribution including USA, Australia, New Zealand, Europe, Southeast Asia, China, Japan, Latin America, and Canada.
  • 제품 설명
    Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, || Model H72, Product is manufactured and distributed by Varian Oncology Systems, || Palo Alto, CA || The product is indicated for use in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy.
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

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