Device Recall Medical Linear Accelerator

  • 모델명 / 제조번호(시리얼번호)
    105285, 105445, 105305, 105532, 105366, 105403, 105265, 105492, 105273, 105186, 105494, 105481, 105395, 105326, 105467, 105392, 105204, 105382, 105093, 105521, 105154, 105387, 105228, 105126, 105514, 105359, 105279, 105518, 105528, 105210, 105482, 105213, 105466, 105284, 105544, 105260, 105194, 105195, 105515, 105386, 105199, 105475, 105117, 105325, 105127, 105498, 105233, 105187, 105478, 105261, 105166, 105321, 105369, 105363, 105437, 105119, 151370, 151889, 151177, 152420, 152003, 151693, 105664, 151211, 105480, 105570, 105501, 105652, 105608, 105792, 105570, 152188, 151483, 105491, 105801, 151746, 151248, 151052, 152195, 151562, 152354, 105338, 152142, 105316, 152213, 152272, 152434, 151354, 151711, 151685, 151201, 151200, 105376, 151822, 151821, 152389, 105373, 151610, 151651, 151876, 151937, 152020, 151105, 151633, 105684, 151372, 151244, 152283, 152317, 152509, 152516, 152590, 151023, 105810, 153165, 152097, 152286, 105793, 151670, 151153, 105427, 105733, 105223, 105281, 105689, 151065, 105970, 151344, 151859, 105346, 105748, 105760, 105680, 151383, 151417, 151797, 105446, 105870, 105292, 105737, 105714, 151158, 151172, 152216, 152557, 152581, 105920, 151536, 105988, 151028, 151174, 151597, 105229, 151600, 105724, 105301, 105422, 105308, 105535, 151494, 151518, 151586, 151814, 151894, 151723, 105613, 151914, 105752, 152284, 105394, 105674, 151183, 105525, 105531, 105634, 105993, 105620, 152575, 152011, 105592, 105450, 151921, 105896, 152092, 105314, 151701, 151922, 151852, 105595, 105361, 105850, 105923, 105554, 105867, 105353, 105934, 105807, 151996, 152224, 151452, 152869, 152065, 105677, 151034, 151891, 105538, 105602, 105778, 105765, 105903, 151719, 151909, 152002, 152083, 151930, 105687, 105711, 151316, 151318, 151088, 105833, 105946, 151378, 151212, 151596, 151658, 151837, 151762, 151815, 105669, 105966, 105795, 105978, 152398, 152032, 151280, 151150, 151984, 151682, 151656, 151045, 151231, 105504, 151017, 151115, 105975, 105974, 105600, 105414, 105429, 105937, 105838, 105758, 151140, 151101, 105915, 151196, 105968, 105943, 151005, 151982, 151988, 151718, 105615, 105958, 151020, 105860, 105863, 105712, 151829, 105955, 151125, 151144, 151620, 152050, 105550, 152251, 152261, 153343, 151438, 152234, 151121, 152346, 151974, 151046, 151448, 105290, 151351, 105415, 105640, 151090, 105703, 105869, 151175, 151094, 151775, 151462, 151474, 151874, 105575, 105617, 105777, 151089, 151735, 151050, 105695, 105635, 105720, 105138, 105412, 105710, 105619, 105781, 152201, 105906, 105412, 105412, 105721, 151079, 105787, 151022, 105742, 151331, 105811, 151032, 151096, 151004, 151136, 105802, 105957, 151292, 152148, 151332, 151486, 151415, 105874, 151225, 105814, 151092, 151692, 105412, 105864, 151418, 105990, 151674, 151399, 151698, 151522, 105883, 151479, 151443, 151422, 105555, 151340, 151051, 151696, 151616, 151785, 151515, 151765, 105630, 151675, 105929, 151024, 151538, 151523, 151519, 151016, 151432, 151260, 105593, 151371, 151084, 151098, 151530, 151099, 151558, 151789, 105754, 151847, 105647, 105898, 151256, 151154, 151579, 105563, 151250, 151828, 105586, 151683, 151764, 151664, 151751, 105776, 105445, 151545, 151073, 151435, 151861, 151886, 151848, 151430, 151864, 151885, 105759, 105925, 105932, 151933, 151955, 151014, 105890, 152031, 105806, 151104, 105678, 105879, 105859, 105580, 151229, 105564, 105660, 151960, 151969, 151076, 151931, 151961, 151954, 152192, 152200, 152392, 151258, 151159, 151684, 151388, 151216
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (Nationwide) including states of: AK, CA, CT, FL, IL, IN, IA, LA, MD, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TN, TX, VA, WA, WV, and Puerto Rico; and countries of: Argentina, Australia, Austria, Belarus, Belgium, Bosnia & Herzegovinia, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Libya, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Russia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
  • 제품 설명
    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator || Used for radiation therapy treatments of malignant neoplastics diseases.
  • Manufacturer
  • 1 Event

제조사

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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 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
  • 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
  • 모델명 / 제조번호(시리얼번호)
    105257, 105803, 105941, 105982, 105984, 151024, 151038, 151051, 151053, 151055, 151073, 151074, 151084, 151110, 151130, 151141, 151151, 151156, 151157, 151160, 151168, 151173, 151178, 151216, 151245, 151250, 151256, 151258, 151259, 151260, 151298, 151301, 151309, 151317, 151319, 151326, 151327, 151328, 151340, 151352, 151359, 151360, 151362, 151363, 151371, 151387, 151391, 151394, 151396, 151398, 151410, 151411, 151412, 151416, 151418, 151423, 151432, 151433, 151435, 151441, 151443, 151446, 151467, 151479, 151504, 151507, 151514, 151515, 151517, 151519, 151521, 151522, 151523, 151530, 151538, 151540, 151545, 151557, 151558, 151566, 151567, 151568, 151574, 151584, 151585, 151587, 151595, 151598, 151601, 151611, 151616, 151623, 151626, 151627, 151628, 151632, 151634, 151636, 151640, 151653, 151664, 151672, 151674, 151675, 151678, 151683, 151684, 151689, 151694, 151695, 151696, 151698, 151699, 151700, 151704, 151705, 151708, 151710, 151714, 151722, 151724, 151728, 151729, 151734, 151736, 151751, 151759, 151760, 151763, 151764, 151765, 151770, 151774, 151779, 151782, 151783, 151785, 151789, 151791, 151793, 151801, 151802, 151803, 151805, 151808, 151809, 151810, 151811, 151812, 151820, 151828, 151839, 151842, 151847, 151848, 151855, 151860, 151864, 151866, 151867, 151875, 151881, 151882, 151885, 151886, 151892, 151931, 151933, 151942, 151952, 151953, 151955, 151956, 151958, 151959, 151960, 151961, 151965, 151969, 151977, 151978, 151981, 151989, 152008, 152019, 152023, 152031, 152043, 152051, 152064, 152079, 152080, 152091, 152098, 152103, 152115, 152116, 152117, 152123, 152126, 152154, 152158, 152163, 152174, 152175, 152176, 152177, 152192, 152200, 152210, 152211, 152214, 152217, 152220, 152222, 152223, 152232, 152246, 152257, 152271, 152301, 152307, 152308
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    Elekta Synergy XVI || Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • Manufacturer