Devices

Device Recall Medical Linear Accelerator

  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator || Used for radiation therapy treatments of malignant neoplastics diseases.
  • Manufacturer
    Elekta, Inc.
  • 1 Event

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 400 Perimeter Center Ter Ne, Ste 50, Atlanta GA 30346-1227
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall Medical Linear Accelerator
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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.
Device Recall Medical linear accelerator (with patient imaging)
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Elekta Synergy XVI || Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • Manufacturer
    Elekta, Inc.