Skip to content
Recall Observatory FDA recall evidence

Device product

SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

Z-1064-2014

May 28, 2013

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 65450
Status
Terminated
Classification
Class II
Quantity
449
Official record key
device-enforcement:Z-1064-2014

Official wording

Reason: Customers are resetting the default values outside recommended factory settings.

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Customers are resetting the default values outside recommended factory settings.