Devices

Device Recall Medical Linear Accelerator

  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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.
  • 1 Event

Fabricant

Elekta, Inc.
  • Adresse du fabricant
    Elekta, Inc., 400 Perimeter Center Ter Ne, Ste 50, Atlanta GA 30346-1227
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    USFDA

2 dispositifs médicaux avec un nom similaire

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Device Recall Medical Linear Accelerator
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator || Used for radiation therapy treatments of malignant neoplastics diseases.
  • Manufacturer
    Elekta, Inc.
Device Recall Medical linear accelerator (with patient imaging)
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution.
  • Description du dispositif
    Elekta Synergy XVI || Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • Manufacturer
    Elekta, Inc.