Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

Recall details

Manufacturer

Elekta, Inc.

Distributor

Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CT, FL, GA, KY, LA, MD, MO, NM, NY, NC, OH, OK, PA, TN, TX, and WA and the countries of Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Poland, Romania, Russia, Saudi Arabia, Senegal, Singapore, Slovakia, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

Lot

152718, 152003, 152007, 151963, 152081, 151693, 152131, 152318, 105792, 105570, 152778, 151052, 152363, 152472, 152195, 153022, 152689, 152640, 152642, 152663, 152680, 152782, 152796, 152829, 152862, 152962, 153030, 153125, 153244, 153270, 153211, 153296, 152834, 152596, 151354, 151353, 152664, 151200, 151823, 151822, 151610, 152026, 152027, 152692, 151276, 152856, 151106, 152877, 152986, 152810, 105935, 153105, 153069, 151023, 152914, 151975, 151240, 151239, 153135, 105810, 153145, 153129, 151182, 151650, 152886, 151850, 152831, 153132, 151343, 153063, 105985, 152832, 152845, 152837, 152863, 152859, 152776, 152857, 152866, 152876, 152820, 152870, 152884, 152865, 152872, 152909, 152910, 152911, 152918, 152934, 152961, 152966, 153009, 153041, 153026, 153078, 153079, 153083, 153070, 153066, 153027, 153154, 153157, 153159, 153165, 153131, 153352, 152675, 152737, 152299, 152403, 152676, 151670, 152252, 151153, 151482, 151296, 152068, 152286, 152097, 151554, 151768, 151853, 151854, 151786, 151495, 151787, 153099, 152935, 151865, 151466, 105920, 152521, 151536, 151263, 105988, 151028, 151058, 152719, 151174, 151597, 152645, 152650, 152647, 105755, 152743, 151857, 151921, 105896, 151986, 152855, 152092, 151006, 151277, 105314, 105919, 152746, 152770, 105901, 151635, 152575, 152627, 151701, 151922, 151852, 152422, 152309, 152498, 152628, 152706, 152616, 105850, 152014, 151688, 151638, 152721, 153234, 152816, 105554, 105987, 151452, 151166, 152913, 151740, 152042, 152904, 152254, 152753, 152554, 152591, 152644, 152607, 152648, 152687, 152714, 152899, 152739, 152672, 152900, 152952, 152977, 153080, 153169, 153183, 152908, 153349, 153325, 152702, 152869, 152724, 151529, 152840, 152841, 151442, 151445, 151612, 151613, 151756, 105677, 151755, 151189, 151034, 151652, 152757, 105893, 105892, 152945, 151060, 105711, 105997. 151324, 151316, 151318, 151385, 152873, 151660, 152734, 152646, 152682, 151087, 151088, 105833, 152613, 152958, 105946, 151117, 151308, 151108, 151280, 151912, 152106, 152157, 152294, 152637, 152624, 152667, 152727, 152726, 152750, 152893, 152953, 151132, 151150, 151879, 151583, 152595, 152733, 153087, 152975, 153310, 153229, 152738, 152735, 152785, 152797, 152947, 153327, 152907, 153291, 153290, 152677, 152674, 151112, 105937, 151349, 105838, 105758, 105927, 151045, 151314, 151553, 151140, 151101, 105995, 105915, 151405, 152638, 152325, 152457, 152512, 151196, 151368, 152118, 152119, 105968, 151040, 105912, 151247, 105943, 151005, 105948, 151341, 151898, 151703, 151982, 152161, 151718, 153059, 151297, 151278, 151020, 105928, 152603, 153084, 152942, 151829, 151284, 152298, 151449, 151144, 151602, 152708, 152713, 152605, 152606, 152614, 152611, 152629, 152679, 152799, 152880, 152928, 152920, 152336, 153343, 153348, 152101, 151669, 151237, 151121, 153205, 151897, 105415, 152793, 105640, 105703, 105869, 151175, 151066, 151233, 152060, 151503, 152190, 153333, 152795, 151089, 152660, 152538, 152827, 152848, 152442, 152846, 152723, 152921, 151119, 152769, 152968, 152143, 152720, 151497, 151197, 151420, 105721, 151079, 105787, 105685, 151511, 151022, 105743, 105742, 151249, 151042, 105786, 151516, 151109, 151331, 151524, 152592, 151255, 105813, 151556, 151526, 105811, 151032, 151581, 151243, 151492, 152070, 151096, 151004, 151136, 105797, 105802, 105957, 105789, 151292, 151425, 151291, 152148, 151332, 151333, 151486, 151415, 151573, 151528, 151487, 151527, 151572, 151414, 105874, 151225, 152653, 105814, 151092, 151047, 151706, 151691, 151692, 151934, 151945, 151946, 153190, 151127, 105412, 152030, 152168, 152396, 152654, 151749, 152891, 152878, 152858, 105894, 151033, 151258, 151168, 151159, 151228, 152760, 151791, 152522, 151391, 151216, 151539, 151611, 151696, 151867, 152965, 151325, 152220, 151785, 152217, 151388, 151394, 151892, 152043, 151793, 151684, 152223, 152303, 152358, 151683, 152652, 152659, 152703, 151672, 152767, 152777, 152783, 152784, 152787, 152798, 152881, 151710, 153045, 152929, 153137.

Risk classification

Class II

Area (FDA)

device

Country

United States