Events

Device Recall Clinac with Version 7.x Software 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
    52636
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1729-2009
  • 사례 시작날짜
    2009-05-29
  • 사례 출판 날짜
    2009-08-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83530
  • 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
    Unexpected movement: if the stereotactic motion disable function is turned on, the couch can be moved via float mode unexpectedly.
  • 조치
    Varian Medical Systems issued an "Urgent Medical Device Correction" dated May 29, 2009 distributed to all affected users, as well as Varian Sales, Marketing and Service organizations, informing them of the issue. Consignees were informed that a Varian Service representative will be in contact to schedule the proper correction. For further questions, contact your local Varian Customer Support District Manager.

Device

Device Recall Clinac with Version 7.x Software
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: H14, H27 and H29, with Version 7.X software.  Code numbers:  H140001 H140136 H140221 H140719 H140759 H140011 H140137 H140222 H140720 H140760 H140018 H140138 H140223 H140721 H140761 H140020 H140139 H140224 H140722 H140762 H140025 H140140 H140225 H140723 H140763 H140026 H140141 H140226 H140724 H140764 H140027 H140142 H140227 H140725 H140765 H140031 H140143 H140228 H140726 H140766 H140043 H140144 H140229 H140727 H140767 H140045 H140145 H140230 H140728 H140768 H140046 H140146 H140231 H140729 H140769 H140047 H140147 H140232 H140730 H140770 H140058 H140148 H140233 H140731 H140771 H140062 H140149 H140234 H140732 H140772 H140067 H140150 H140235 H140733 H140773 H140070 H140151 H140236 H140734 H140774 H140071 H140152 H140237 H140735 H140775 H140073 H140153 H140238 H140736 H140776 H140076 H140154 H140239 H140737 H140777 H140077 H140201 H140240 H140739 H140778 H140088 H140202 H140700 H140740 H140779 H140090 H140203 H140701 H140741 H140780 H140092 H140204 H140702 H140742 H140781 H140096 H140205 H140703 H140743 H140782 H140097 H140206 H140704 H140744 H140783 H140098 H140207 H140705 H140745 H140784 H140101 H140208 H140706 H140746 H140785 H140109 H140209 H140707 H140747 H140786 H140111 H140210 H140708 H140748 H140787 H140114 H140211 H140709 H140749 H140788 H140115 H140212 H140710 H140750 H140789 H140117 H140213 H140711 H140751 H140790 H140119 H140214 H140712 H140752 H140791 H140121 H140215 H140713 H140753 H140792 H140124 H140216 H140714 H140754 H140793 H140125 H140217 H140715 H140755 H140794 H140133 H140218 H140716 H140756 H140795 H140134 H140219 H140717 H140757 H140796 H140135 H140220 H140718 H140758 H140797 H272394 H272859 H273049 H273132 H273179 H272397 H272860 H273053 H273133 H273180 H272401 H272862 H273055 H273134 H273181 H272405 H272866 H273056 H273135 H273182 H272407 H272868 H273063 H273136 H273183 H272410 H272872 H273064 H273137 H273184 H272418 H272873 H273065 H273138 H273185 H272421 H272875 H273066 H273139 H273186 H272422 H272885 H273072 H273140 H273187 H272425 H272889 H273077 H273141 H273188 H272426 H272893 H273080 H273142 H273189 H272427 H272905 H273082 H273143 H273190 H272428 H272908 H273083 H273144 H273191 H272434 H272909 H273084 H273145 H273192 H272454 H272922 H273092 H273146 H273193 H272456 H272926 H273101 H273147 H273194 H272458 H272932 H273102 H273148 H273195 H272466 H272938 H273103 H273149 H273196 H272469 H272946 H273104 H273150 H273197 H272470 H272956 H273105 H273151 H273198 H272473 H272960 H273106 H273152 H273199 H272479 H272964 H273107 H273153 H273200 H272480 H272971 H273108 H273155 H273201 H272488 H272973 H273109 H273156 H273202 H272492 H272978 H273110 H273157 H273203 H272494 H272981 H273111 H273158 H273204 H272497 H272982 H273112 H273159 H273205 H272500 H272985 H273113 H273160 H273206 H272801 H272986 H273114 H273162 H273208 H272803 H272987 H273115 H273163 H273209 H272811 H272990 H273116 H273164 H273210 H272816 H272996 H273117 H273165 H273528 H272822 H272999 H273118 H273166 H273547 H272824 H273004 H273119 H273167 H273578 H272825 H273011 H273120 H273168 H273711 H272826 H273016 H273121 H273169 H273929 H272828 H273026 H273122 H273170 H290201 H272834 H273027 H273123 H273171 H290222 H272837 H273030 H273124 H273172 H290224 H272841 H273031 H273125 H273173 H290241 H272842 H273036 H273126 H273174 H290243 H272846 H273039 H273127 H273175 H290249 H272848 H273040 H273128 H273176 H290262 H272854 H273042 H273130 H273177 H290263 H272857 H273048 H273131 H273178 H290274 H291176 H291221 H291266 H293333 H293379 H291177 H291222 H291267 H293334 H293380 H291178 H291223 H291268 H293335 H293381 H291179 H291224 H291269 H293336 H293382 H291180 H291225 H291270 H293337 H293383 H291181 H291226 H291271 H293339 H293384 H291182 H291227 H291272 H293340 H293385 H291183 H291228 H291273 H293341 H293386 H291184 H291229 H292366 H293342 H293387 H291185 H291230 H292832 H293343 H293388 H291186 H291231 H293009 H293344 H293389 H291187 H291232 H293207 H293345 H293390 H291188 H291233 H293300 H293346 H293391 H291189 H291234 H293301 H293347 H293392 H291190 H291235 H293302 H293348 H293393 H291191 H291236 H293303 H293349 H293394 H291192 H291237 H293304 H293350 H293395 H291193 H291238 H293305 H293351 H293396 H291194 H291239 H293306 H293352 H293397 H291195 H291240 H293307 H293353 H293398 H291196 H291241 H293308 H293354 H293399 H291197 H291242 H293309 H293355 H293401 H291198 H291243 H293310 H293356 H293402 H291199 H291244 H293311 H293357 H293403 H291200 H291245 H293312 H293358 H293404 H291201 H291246 H293313 H293359 H293405 H291202 H291247 H293314 H293360 H293406 H291203 H291248 H293315 H293361 H293407 H291204 H291249 H293316 H293362 H293408 H291205 H291250 H293317 H293363 H293409 H291206 H291251 H293318 H293364 H293410 H291207 H291252 H293319 H293365 H293411 H291208 H291253 H293320 H293366 H293412 H291209 H291254 H293321 H293367 H293413 H291210 H291255 H293322 H293368 H293414 H291211 H291256 H293323 H293369 H293415 H291212 H291257 H293324 H293370 H293416 H291213 H291258 H293325 H293371 H293417 H291214 H291259 H293326 H293372 H293418 H291215 H291260 H293327 H293373 H293419 H291216 H291261 H293328 H293374 H293420 H291217 H291262 H293329 H293375 H293421 H291218 H291263 H293330 H293376 H293422 H291219 H291264 H293331 H293377 H293423 H291220 H291265 H293332 H293378 H293424 H293655 H293702 H293750 H293798 H293846 H293656 H293703 H293751 H293799 H293847 H293657 H293704 H293752 H293800 H293848 H293658 H293705 H293753 H293801 H293849 H293659 H293706 H293754 H293802 H293850 H293660 H293707 H293755 H293803 H293851 H293661 H293708 H293756 H293804 H293852 H293662 H293709 H293758 H293805 H293853 H293663 H293710 H293759 H293806 H293854 H293664 H293712 H293760 H293807 H293855 H293665 H293713 H293761 H293808 H293856 H293666 H293714 H293762 H293809 H293857 H293667 H293715 H293763 H293812 H293858 H293668 H293716 H293764 H293813 H293859 H293669 H293717 H293765 H293814 H293860 H293670 H293718 H293767 H293815 H293861 H293671 H293719 H293769 H293816 H293862 H293672 H293720 H293770 H293817 H293863 H293673 H293721 H293771 H293818 H293864 H293674 H293723 H293772 H293819 H293865 H293675 H293724 H293773 H293820 H293866 H293676 H293725 H293774 H293821 H293867 H293678 H293726 H293775 H293822 H293868 H293679 H293727 H293776 H293823 H293869 H293681 H293728 H293777 H293824 H293870 H293682 H293729 H293778 H293825 H293871 H293683 H293730 H293779 H293826 H293872 H293684 H293732 H293780 H293827 H293873 H293685 H293733 H293781 H293828 H293874 H293686 H293734 H293782 H293829 H293875 H293687 H293735 H293783 H293830 H293876 H293688 H293736 H293784 H293831 H293877 H293689 H293737 H293785 H293832 H293878 H293690 H293738 H293786 H293834 H293879 H293691 H293739 H293787 H293835 H293880 H293692 H293740 H293788 H293836 H293881 H293693 H293741 H293789 H293837 H293882 H293694 H293742 H293790 H293838 H293883 H293695 H293743 H293791 H293839 H293884 H293696 H293744 H293792 H293840 H293885 H293697 H293745 H293793 H293841 H293886 H293698 H293746 H293794 H293842 H293887 H293699 H293747 H293795 H293843 H293888 H293700 H293748 H293796 H293844 H293889 H293701 H293749 H293797 H293845 H293890 H294134 H294186 H294240 H294299 H294135 H294187 H294241 H294301 H294136 H294188 H294242 H294302 H294137 H294189 H294243 H294303 H294138 H294190 H294244 H294304 H294140 H294191 H294245 H294306 H294142 H294192 H294246 H294307 H294143 H294193 H294247 H294308 H294144 H294194 H294252 H294309 H294145 H294195 H294254 H294312 H294146 H294196 H294256 H294314 H294148 H294197 H294257 H294316 H294149 H294198 H294258 H294317 H294150 H294199 H294261 H294318 H294151 H294200 H294262 H294320 H294152 H294201 H294263 H294321 H294154 H294202 H294264 H294322 H294155 H294203 H294266 H294323 H294156 H294204 H294267 H294324 H294157 H294205 H294269 H294325 H294158 H294207 H294270 H294326 H294159 H294208 H294271 H294327 H294161 H294209 H294272 H294328 H294162 H294210 H294273 H294330 H294163 H294214 H294275 H294331 H294164 H294216 H294276 H294332 H294165 H294217 H294277 H294333 H294166 H294218 H294278 H294334 H294167 H294219 H294279 H294336 H294168 H294220 H294280 H294337 H294169 H294221 H294281 H294338 H294170 H294222 H294282 H294340 H294172 H294223 H294283 H294341 H294173 H294224 H294285 H294342 H294174 H294225 H294286 H294343 H294175 H294226 H294287 H294348 H294176 H294227 H294288 H294350 H294177 H294228 H294289 H294353 H294178 H294230 H294290 H294354 H294179 H294232 H294293 H294355 H294180 H294234 H294294 H294358 H294181 H294235 H294295 H294360 H294182 H294236 H294296 H294361 H294184 H294237 H294297 H294363 H294185 H294239 H294298 H294364
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Clinac with Version 7.x Software, manufactured by Varian Medical Systems, Palo Alto, CA. || Part of the Trilogy Radiotherapy Delivery System for radiation therapy intended to delivery megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy.
  • 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