Elekta, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1322-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 28, 2013

Date Posted: April 9, 2014

Recall Number: Z-1322-2014

Event ID: 67574

Reason for Recall:

The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.

Status: Terminated

Product Quantity: 498

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated