Events

Retiro De Equipo (Recall) de Device Recall Precise Treatment Table

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
    64664
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1072-2013
  • Fecha de inicio del evento
    2013-03-14
  • Fecha de publicación del evento
    2013-04-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116734
  • 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
    Couch, radiation therapy, powered - Product Code JAI
  • Causa
    The column rotation can accidentally be moved to a different position which in the locked position.
  • Acción
    Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated March 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Elekta office for questions about this notice.

Device

Device Recall Precise Treatment Table
  • Modelo / Serial
    151855, 151611, 152008, 151587. 151694, 152019, 105864, 105932, 151574, 151267, 152397, 152248, 152559, 151875, 151965, 151369, 152502, 105829, 152262, 151504, 151159, 105941, 151418, 151538, 105990, 151674, 105555, 151729, 151399, 105809, 151802, 151421, 152427, 129032, 105803, 152652. 152659, 152715, 152117, 152803, 151566, 152271, 151736, 151700, 105895, 151866, 151259, 151698, 151699, 151636, 151539, 152454, 151811, 105782, 152425, 151568, 105126, 151390, 152452, 151258, 152491, 105590, 151167, 105853, 105854, 152356, 151584, 105494, 151989, 151522, 151317, 105925, 151055, 151423, 151110, 151981, 151808, 151360, 152801, 151367, 151769, 151969, 105894, 152043, 151391, 151708, 151033, 151809, 151098, 151099, 105841, 152205, 105325, 151763, 151695, 151507, 152703, 105883, 105914, 151238, 151540, 151640, 152777, 152163, 151623, 151627, 151380, 151479, 152331, 152200, 152192, 105481, 151933, 152126, 152115, 152116, 152475, 151422, 152802, 152927, 152123, 151076, 151363, 151954, 105992, 151955, 151340, 105950, 151014, 105273, 152388, 151722, 105154, 105731, 152154, 105284, 151724, 151779, 105644, 152091, 105559, 105844, 151178, 151093, 152585, 105960, 151810, 151467, 151678, 152176, 151051, 151848, 151849, 151411, 151216, 151430, 151173, 151931, 151696, 151616, 151867, 105195, 151141, 151228, 151433, 151977, 105728, 152732, 152833, 105359, 151151, 151714, 105646, 129016, 152815, 152023, 105773, 105260, 105890, 152362, 152359, 152353, 152352, 152433, 105199, 151653, 152303, 152358, 151892, 152223, 152767, 105846, 152881, 151515, 151861, 152618, 105630, 151675, 105591, 151059, 152305, 151325, 152787, 152468, 152031, 152469, 152481, 152601, 151709, 151029, 151886, 151956, 151812, 105929, 151024, 151860, 151523, 105568, 105936, 129029, 151803, 105881, 105261, 105806, 129041, 151885, 105868, 151260, 151519, 151432, 151783, 152175, 152232, 152177, 152365, 151952, 152257, 105528, 152798, 151410, 151084, 105593, 151371, 151305, 105969, 151016, 152220, 151774, 152217, 105926, 151435, 151978, 151387, 151734, 151626, 151842, 105872, 151530, 105636, 129012, 151328, 152673, 151176, 152371, 151080, 152370, 152604, 105856, 151759, 151689, 151942, 151567, 151601, 151598, 151960, 151958, 151959, 152364, 152792, 151820, 152717, 151557, 151558, 105666, 151760, 105902, 105998, 129015, 151319, 105567, 151269, 151253, 151396, 151104, 105678, 105514, 105879, 151705, 151770, 105321, 152098, 152246, 151789, 152103, 151309, 152301, 152446, 105754, 151634, 105982, 151160, 152155, 152600, 152599, 151388, 151394, 151793, 105859, 105759, 152210, 152211, 151398, 151632, 151015, 152214, 105580, 151704, 151446, 152520, 151143, 152158, 151765, 151301, 151962, 151785, 105837, 152392, 151847, 105699, 105647, 105898, 151684, 152784, 151441, 105660, 129018, 151038, 152530, 151229, 152593, 105564, 152536, 152483, 105886, 151256, 152678, 105117, 151864, 151839, 151154, 151168, 151537, 151155, 151156, 151157, 151491, 105984, 151412, 151801, 105492, 151728, 105910, 151521, 151053, 151359, 152783, 152448, 152079, 152080, 105949, 152307, 152308, 105624, 105563, 151585, 105882, 151326, 151327, 151443, 151828, 151130, 151250, 151882, 151881, 105812, 105796, 151245, 105586, 151683, 151764, 152504, 129024, 151416, 152064, 152222, 152373, 151579, 151961, 105621, 105532, 151664, 151953, 105657, 151751, 152036, 105610, 151134, 151266, 152828, 152432, 151672, 151074, 151595, 151008, 152174, 105770, 105776, 105445, 151352, 151545, 152207, 151628, 105723, 151362, 151298, 105386, 151073, 152549, 151710, 151791, 151514, 152522
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution and Puerto Rico.
  • Descripción del producto
    Precise Treatment Table. || To be used as part of radiation therapy treatment process.
  • 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