Events

Rappel de Device Recall Precise Digital Accelerator

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Elekta, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75052
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2721-2016
  • Date de mise en oeuvre de l'événement
    2016-07-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-11-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149195
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Accelerator, linear, medical - Product Code IYE
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    Medical Linear Accelerator
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Adresse du fabricant
    Elekta, Inc., 400 Perimeter Center Ter NE Ste 50, Atlanta GA 30346-1227
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    USFDA