—#149195

Product

Medical Linear Accelerator

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K051932
Affected lot / code info: 105639, 105652, 105608, 151187, 151401, 105792, 105570, 151577, 151563, 151562, 151444, 151347, 151746, 105557, 151434, 105801, 151702, 151052, 151384, 151661, 105873, 151138, 105875, 151606, 151246, 151649, 105729, 151642, 105820, 151097, 151063, 105857, 105952, 151227, 151208, 105935, 151345, 151120, 151057, 151018, 105684, 151122, 105573, 105973, 105688, 105768, 151078, 105908, 151039, 151323, 105953, 151607, 151023, 151164, 151304, 105569, 105900, 151070, 151293, 151548, 151631, 151618, 151609, 151547, 151105, 105994, 151437, 151124, 105597, 105839, 105947, 105753, 151205, 151240, 151239, 151382, 105779, 151490, 105732, 151270, 151648, 151232, 151440, 151307, 151408, 105552, 151485, 105746, 105745, 151276, 105889, 151147, 151056, 151294, 105830, 151592, 151286, 151282, 151118, 151381, 151375, 151376, 151400, 151593, 151508, 151589, 151590, 151637, 151726, 151721, 151707, 151750, 151742, 105897, 151342, 151069, 151019, 151163, 105747, 151407, 151182, 151081, 151646, 151113, 105605, 151106, 151242, 151337, 151641, 105917, 105899, 151564, 151591, 151021, 151535, 105933, 151290, 105985, 151068, 151343, 151027, 151732, 151218, 151219, 151220, 105735, 151554, 151192, 105834, 105752, 105642, 105599, 151191, 105674, 151645, 151131, 151111, 151277, 105993, 105634, 105919, 105848, 105620, 105579, 151402, 151193, 105740, 105613, 151257, 105901, 151283, 151355, 151635, 151202, 105877, 105756, 151221, 151518, 151575, 105592, 105733, 105965, 105940, 151139, 151409, 151204, 151230, 151559, 151146, 151152, 105824, 105662, 105651, 105730, 105623, 105686, 151758, 105670, 151261, 151048, 151279, 105931, 105631, 151665, 151126, 151426, 151037, 151036, 151513, 151738, 151543, 151339, 105689, 151753, 151174, 151745, 105755, 151473, 151241, 105737, 105999, 105920, 151668, 151013, 151336, 105817, 105804, 151603, 151395, 105748, 105996, 151536, 151172, 151392, 151100, 151210, 151161, 105680, 151263, 151058, 151028, 105842, 151417, 151331, 151109, 105743, 105742, 105635, 151004, 105802, 105797, 105786, 105695, 151478, 105906, 105904, 151527, 151487, 151486, 151415, 151414, 105813, 151413, 105720, 151188, 105781, 151032, 105638, 105957, 105789, 105769, 105814, 105874, 151692, 105595, 105583, 105581, 105850, 105607, 151475, 151688, 105554, 105923, 105980, 105867, 151731, 151614, 151615, 105991, 151123, 151350, 151484, 151389, 105677, 151034, 151464, 105976, 105641, 151499, 151166, 151133, 105683, 151082, 105807, 151041, 151452, 151740, 151195, 151031, 105934, 105835, 151271, 105946, 105602, 151088, 151087, 151720, 151206, 151622, 151621, 151102, 105778, 105763, 105574, 105852, 151060, 105791, 105679, 105663, 105702, 105701, 105681, 151199, 151061, 151209, 151660, 105825, 105622, 105983, 151324, 105572, 105767, 151505, 105643, 151427, 105938, 105562, 105808, 105885, 105893, 105892, 105628, 105589, 151274, 151273, 105687, 105603, 105939, 105878, 151667, 105997, 105711, 105903, 105765, 151525, 105780, 105833, 151150, 151730, 151357, 151506, 105978, 151117, 105966, 151551, 151561, 105849, 151234, 151265, 151287, 151252, 151203, 151280, 151468, 151619, 151761, 105862, 151747, 151272, 151681, 105795, 151565, 105669, 105799, 151064, 151108, 151235, 151103, 151302, 151459, 151448, 105715, 151226, 105749, 151741, 105986, 151476, 151555, 151716, 151715, 151310, 151315, 105937, 105758, 105927, 151101, 105915, 151224, 151213, 105661, 151017, 151000, 151040, 151299, 105975, 105974, 105943, 151171, 151005, 105948, 105615, 105863, 105860, 151713, 151520, 151712, 105783, 105712, 151454, 105964, 151671, 151438, 151007, 151534, 105640, 105861, 105869, 105703, 151233, 151066, 151237, 151121, 151669, 151135, 151119, 151542, 151509, 151451, 151181, 151011, 151010, 151533, 151532, 151356, 151329, 151544, 151733, 151725, 151262, 105762, 105951, 151142, 105972, 105764, 151071, 105576, 105930, 151137, 151541, 151089, 105777, 151085, 105575, 105866, 151165, 151179, 105782, 105881, 105646, 151008, 151167, 105844, 105829, 151154, 151099, 151098, 151029, 105886, 151695, 105754.151266, 151134, 151305, 105593, 105837, 151537, 151016, 105969, 151238, 105883, 105563, 105666, 151421, 105744, 151228, 105929, 105564, 105894, 105895, 105846, 105624, 105841, 151325, 105568, 105660, 105806, 151422, 105960, 105925, 105949, 105898, 105699, 105872, 151229, 105864, 105678, 151093, 105759, 151320, 151456, 151457, 151639, 151687, 151148, 151373, 151149, 151321, 151374, 151322, 105847, 151549, 151365, 151083

Why it was recalled

There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

Root cause (FDA determination)

Other

Action the firm took

Important Field Safety Notice 200-01-103-081 was released July 8, 2016 for distribution to all customers with Digital Accelerators without XVI. It informs users of the specific product and version numbers affected by the issue. The modification involves an inspection and correction procedure. Should the inspection pass, the corrected in not required. All gantry base wheel bolts should be checked for presence and torque and should be replaced if found to be showing signs of fatigue. Elekta service is actively reaching out to affected customers in order to organize a time to implement the inspection and correction. The notice included an acknowledgment form to be returned.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: AL, AZ, CA, FL, GA, KY, MI, MN, MO, NE, NJ, NY, NC, OH, OK, PA, SC, TX, WA, WV, Argentina, Austria, Australia, Bosnia and Herzegovinia, Bangladesh, Belgium, Bulgaria, Brazil, China, Columbia, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iran, Italy, Japan, Jordan, Lebanon, Libya, Morocco, Mexico, Nigeria, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Portugal, Serbia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, Yemen

Timeline

Recall initiated: 2016-07-08
Terminated: 2017-11-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149195. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.