Device Recall 4D Integrated Treatment Console (4DITC) 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
    59351
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3100-2011
  • 사례 시작날짜
    2011-06-27
  • 사례 출판 날짜
    2011-08-30
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-12-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    In certain configurations, the 4ditc can interpret a rapidarc or vmat treatment field as 3d conformal arc treatment plan. if a rapidarc or vmat treatment field is incorrectly interpreted as conformal arc, the field will be delivered with a constant dose rate and gantry speed for the entire duration of the delivery, which can lead to delivered dose being different than planned.
  • 조치
    Varian sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated June 27, 2011 to all affected customers. The letter identified the product, problem and recommended user actions to follow. Customers were instructed to notify all appropriate personnel of the correction notice. The letter states that Varian Service will contact customers to arrange to perform update to 4D Integrated Treatment Console (4DITC) software. For further clarification, contact your local Varian Customer Support District or Regional Manager. The letter also provides Varian Oncology Help desk contact information 1-888-827-4265 for USA and Canada and +41417498844 for Europe.

Device

  • 모델명 / 제조번호(시리얼번호)
    H510015, H511960, H513012, H513971, H514364, H514613, H514915, H515118, H515267, H515410, H515634, H510074, H511996, H513039, H513973, H514366, H514614, H514919, H515121, H515270, H515412, H515641, H510171, H512014, H513046, H513978, H514367, H514615, H514920, H515123, H515275, H515413, H515644, H510285, H512048, H513054, H513990, H514375, H514617, H514927, H515127, H515278, H515416, H515653, H510457, H512049, H513069, H513999, H514378, H514620, H514932, H515129, H515280, H515417, H515669, H510494, H512078, H513095, H514006, H514387, H514624, H514933, H515130, H515282, H515420, H515676, H510565, H512090, H513125, H514015, H514392, H514625, H514937, H515132, H515283, H515424, H515680, H510610, H512133, H513195, H514020, H514394, H514626, H514948, H515134, H515284, H515427, H515686, H510683, H512134, H513200, H514028, H514401, H514629, H514949, H515135, H515285, H515428, H515690, H510686, H512137, H513224, H514048, H514406, H514634, H514952, H515138, H515286, H515430, H515691, H510783, H512169, H513229, H514060, H514410, H514641, H514953, H515142, H515288, H515432, H515692, H510785, H512259, H513242, H514064, H514413, H514642, H514970, H515143, H515295, H515433, H515698, H510822, H512260, H513246, H514079, H514437, H514643, H515004, H515144, H515297, H515439, H515703, H510823, H512264, H513254, H514084, H514438, H514644, H515009, H515145, H515300, H515442, H515705, H510834, H512266, H513261, H514096, H514456, H514648, H515011, H515147, H515303, H515443, H515713, H510852, H512274, H513277, H514097, H514460, H514653, H515013, H515148, H515304, H515445, H515714, H510863, H512283, H513279, H514100, H514469, H514660, H515014, H515150, H515306, H515447, H515716, H510889, H512345, H513301, H514101, H514474, H514662, H515017, H515151, H515310, H515451, H515723, H510920, H512436, H513306, H514112, H514481, H514670, H515018, H515152, H515314, H515455, H515730, H511043, H512471, H513341, H514114, H514482, H514672, H515019, H515158, H515315, H515461, H515732, H511064, H512492, H513362, H514122, H514483, H514675, H515020, H515161, H515318, H515462, H515740, H511066, H512495, H513405, H514146, H514486, H514677, H515021, H515162, H515320, H515463, H515742, H511073, H512498, H513433, H514161, H514488, H514678, H515024, H515169, H515321, H515467, H515743, H511130, H512511, H513450, H514173, H514489, H514682, H515027, H515171, H515322, H515472, H515771, H511132, H512536, H513471, H514185, H514494, H514683, H515033, H515173, H515323, H515474, H515778, H511149, H512537, H513498, H514186, H514497, H514689, H515034, H515174, H515325, H515475, H515796, H511152, H512539, H513499, H514187, H514499, H514691, H515038, H515175, H515327, H515478, H515809, H511153, H512573, H513510, H514192, H514506, H514692, H515039, H515178, H515328, H515480, H515810, H511166, H512576, H513525, H514198, H514514, H514702, H515046, H515179, H515332, H515482, H515811, H511202, H512578, H513542, H514216, H514515, H514711, H515049, H515181, H515336, H515487, H515813, H511285, H512579, H513545, H514219, H514516, H514716, H515050, H515184, H515337, H515490, H515819, H511286, H512600, H513551, H514227, H514517, H514732, H515056, H515189, H515339, H515491, H515820, H511322, H512602, H513554, H514236, H514520, H514752, H515059, H515196, H515340, H515492, H515840, H511326, H512621, H513604, H514237, H514521, H514759, H515060, H515197, H515342, H515494, H515846, H511361, H512647, H513645, H514238, H514523, H514763, H515061, H515198, H515346, H515501, H515879, H511364, H512652, H513646, H514241, H514530, H514768, H515063, H515200, H515353, H515506, H515888, H511398, H512676, H513650, H514250, H514534, H514769, H515064, H515205, H515354, H515507, H515902, H511412, H512677, H513691, H514262, H514540, H514781, H515070, H515208, H515355, H515510, H515947, H511434, H512678, H513697, H514265, H514541, H514782, H515071, H515210, H515358, H515511, H515979, H511491, H512679, H513741, H514268, H514546, H514783, H515072, H515211, H515362, H515514, H515983, H511504, H512680, H513742, H514285, H514555, H514794, H515073, H515212, H515363, H515515, H516012, H511538, H512681, H513749, H514288, H514556, H514804, H515075, H515213, H515366, H515516, H518171, H511551, H512695, H513761, H514289, H514560, H514805, H515078, H515214, H515373, H515523, H518187, H511554, H512713, H513766, H514291, H514561, H514812, H515082, H515215, H515376, H515527, H518200, H511584, H512758, H513783, H514306, H514572, H514817, H515086, H515218, H515379, H515529, H51B031, H511656, H512774, H513790, H514316, H514574, H514820, H515088, H515224, H515380, H515531, H511673, H512783, H513802, H514329, H514575, H514821, H515090, H515225, H515381, H515534, H511698, H512786, H513805, H514331, H514578, H514824, H515091, H515227, H515382, H515535, H511707, H512787, H513826, H514332, H514579, H514826, H515092, H515232, H515384, H515536, H511745, H512813, H513841, H514337, H514580, H514827, H515097, H515238, H515385, H515538, H511765, H512819, H513842, H514342, H514581, H514843, H515099, H515242, H515387, H515539, H511800, H512822, H513845, H514343, H514584, H514851, H515100, H515246, H515394, H515547, H511806, H512831, H513860, H514345, H514596, H514855, H515101, H515252, H515398, H515552, H511845, H512888, H513863, H514346, H514602, H514856, H515105, H515257, H515399, H515562, H511916, H512929, H513873, H514348, H514603, H514857, H515107, H515258, H515400, H515566, H511917, H512966, H513911, H514349, H514604, H514863, H515108, H515260, H515403, H515596, H511932, H512967, H513912, H514350, H514605, H514875, H515110, H515262, H515405, H515604, H511937, H512992, H513944, H514357, H514608, H514876, H515115, H515263, H515407, H515613, H511951, H512995, H513952, H514359, H514609, H514895, H515116, H515264, H515408, H515623, H511959, H513004, H513955, H514362, H514612, H514905, H515117, H515265, H515409, H515628A
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide)
  • 제품 설명
    Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc Treatment Plan as a 3D Conformal Arc Treatment Plan; version v8.6 or 8.8 in combination with treatment planning systems; Model Number: H51; Reference/PSCA Identifier: CP-03063; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || Product Usage: 4D Integrated treatment console is designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
  • Manufacturer

Manufacturer

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