Events

Device Recall Medical Linear Accelerator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Elekta, Inc. 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
    65451
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1065-2014
  • 사례 시작날짜
    2013-05-28
  • 사례 출판 날짜
    2014-03-07
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118951
  • 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
    Customers are resetting the default values outside recommended factory settings.
  • 조치
    Elekta sent an Important Field Safety Notice dated May 2013 to all affected customers. The Notice identified the affected product, problem, clinical impact and actions to be taken. Customers were instructed to adhere to the instructions and advice given in manuals and system dialogues. For question contact your local Elekta office.

Device

Device Recall Medical Linear Accelerator
  • 모델명 / 제조번호(시리얼번호)
    151855, 151587, 152246, 151694, 152019, 105864, 151729, 105932, 151574, 152397, 152559, 152248, 151875, 153036, 153072, 151965, 151076, 151363, 152448, 105782, 151110, 105841, 105731, 105989, 152154, 151093, 151369, 105727, 151705, 151954, 152502, 152454, 152262, 151504, 105941, 151418, 105990, 151674, 105555, 151399, 105809, 151802, 105610, 151134, 151421, 105716, 105717, 152427, 105829, 153035, 105910, 152117, 152803, 151566, 151033, 152271, 151736, 151700, 151866, 151259, 151698, 151699, 151539, 151517, 151636, 151811, 105584, 151568, 152452, 151390, 152960, 151258, 151159, 152051, 153045, 151708, 152425, 151267, 152939, 152491, 105590, 151167, 105853, 105854, 152356, 152959, 151584, 151989, 105894, 151391, 151317, 151522, 105925, 151055, 151423, 151981, 151808, 152801, 152970, 151367, 151769, 151969, 153019, 153021, 151977, 151809, 152205, 151763, 151695, 151507, 151623, 151627, 105883, 105914, 151238, 152703, 151640, 152163, 151380, 151479, 152200, 152192, 151933, 152126, 152475, 152115, 152116, 152965, 151422, 152802, 152927, 152123, 105992, 105950, 151955, 151340, 153061, 151014, 151722, 152222, 151025, 151724, 151779, 152652, 152659, 152715, 152091, 105559, 105844, 151178, 152585, 105960, 151810, 151467, 151678, 151791, 152522, 151514, 152176, 151051, 151848, 151849, 151411, 153030, 151216, 151430, 151173, 151931, 151696, 152373, 151077, 152388, 151616, 151867, 151008, 151595, 152948, 151141, 151228, 152365, 151433, 151611, 152008, 105728, 152732, 151151, 152833, 151714, 105646, 152815, 152023, 151095, 105773, 105587, 105890, 152433, 152954, 151653, 152223, 152303, 152767, 152358, 151892, 151785, 105846, 152352, 152353, 152359, 152362, 152881, 151515, 105828, 151360, 151704, 151765, 151325, 152618, 105591, 151035, 151059, 151861, 152946, 105630, 151675, 152305, 152468, 152787, 151538, 152031, 152469, 152481, 152601, 153114, 105644, 151709, 151029, 105561, 151886, 151956, 105929, 151024, 151860, 151523, 151521, 105568, 105936, 151803, 153050, 105881, 105806, 151885, 105868, 151260, 151519, 151432, 151783, 152175, 152232, 152177, 152604, 151952, 152257, 152798, 151410, 153032, 105593, 151371, 151084, 151098, 152792, 105969, 151030, 151774, 152220, 151016, 152217, 105926, 105676, 105621, 151435, 151319, 151387, 151978, 151734, 152446, 105872, 151530, 105636, 151328, 152673, 151176, 152371, 151080, 152370, 151689, 105856, 105918, 151759, 151626, 151842, 151942, 151567, 151598, 151601, 151958, 151959, 151960, 152364, 151820, 152717, 105666, 151760, 105902, 105998, 105637, 151253, 151269, 151396, 151104, 151770, 151864, 105678, 105879, 151782, 152098, 151099, 151557, 151558, 151789, 152210, 152211, 105649, 151309, 152103, 152301, 105754, 105982, 151160, 151634, 152155, 152599, 152600, 152963, 151388, 151394, 151793, 105859, 105759, 151305, 105774, 151398, 151540, 151632, 151015, 152214, 152520, 152955, 105580, 151446, 151143, 152158, 151301, 151962, 152392, 105837, 151847, 105647, 105699, 105705, 105898, 151684, 152784, 105660, 151038, 152530, 151229, 152593, 151441, 152483, 152536, 105564, 105565, 153046, 105886, 151256, 152678, 153037, 151154, 151168, 151839, 151537, 151155, 151156, 151157, 151491, 151579, 105585, 152043, 151801, 105744, 105984, 151412, 105567, 151728, 153071, 151053, 151359, 105624, 152079, 152080, 105949, 152783, 152307, 152308, 105563, 105648, 105655, 151585, 105882, 151326, 151327, 151443, 152331, 151130, 151250, 151828, 151881, 151882, 151245, 105796, 105812, 152504, 105586, 151683, 151764, 105612, 151416, 105566, 152064, 151961, 152916, 151664, 151953, 105657, 151751, 152036, 151266, 152828, 152432, 151812, 151672, 151074, 152174, 105770, 105772, 105776, 151352, 151298, 105257, 105803, 151545, 151628, 152207, 152817, 152818, 105723, 151362, 151073, 153068, 152549, 151710
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA Nationwide Distribution in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC and including Puerto Rico.
  • 제품 설명
    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads || Product Usage: Deliver of radiation to defined target volumes
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • 제조사 주소
    Elekta, Inc., 400 Perimeter Center Ter Ne, Ste 50, Atlanta GA 30346-1227
  • 제조사 모회사 (2017)
    Elekta AB
  • Source
    USFDA