Events

Retiro De Equipo (Recall) de Device Recall Precise Digital Accelerator

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Elekta, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    75052
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2721-2016
  • Fecha de inicio del evento
    2016-07-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149195
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Accelerator, linear, medical - Product Code IYE
  • Causa
    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.
  • Acción
    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.

Device

Device Recall Precise Digital Accelerator
  • Modelo / Serial
    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
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    Medical Linear Accelerator
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Dirección del fabricante
    Elekta, Inc., 400 Perimeter Center Ter NE Ste 50, Atlanta GA 30346-1227
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    USFDA