Events

Retiro De Equipo (Recall) de Device Recall The Elekta Synergy System

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
    58874
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3079-2011
  • Fecha de inicio del evento
    2011-05-06
  • Fecha de publicación del evento
    2011-08-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100456
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
  • Causa
    A small number of the modular reverse diodes (d1a), a component in the equipment room of the elekta linear accelerator, have ruptured.
  • Acción
    ELEKTA sent an IMPORTANT NOTICE (FCO 20000103022), dated May 6, 2011. The notice identified the product, the problem, and the aciton to be taken by the customer. Elekta recommended that service personnel always wear protective safety glasses, when they do work on the modulator assembly with the covers removed. Elekta also recommended that users make sure that the modulator cover is installed when the digital accelerator is in operation. Elekta will release a Field Change Order when a corrective action is identified.

Device

Device Recall The Elekta Synergy System
  • Modelo / Serial
    151855, 151340, 151587, 152246, 151694, 105864, 105932, 105559, 151574, 152397, 151803, 151875, 151521, 151965, 151504, 151159, 105941, 151418, 151538, 105555, 151728, 151729, 151399, 105809, 151802, 151421, 105723, 105803, 151362, 151545, 151628, 151566, 152271, 151736, 151700, 151866, 151698, 151699, 151517, 151539, 151636, 151695, 151696, 151981, 105837, 151811, 105584, 151568, 151390, 151258, 151360, 151328, 105590, 151167, 151584, 151317, 151522, 105925, 151055, 151808, 151367, 151769, 151969, 151801, 151977, 105894, 151033, 151391, 151708, 152043, 151267, 151809, 152205, 152019, 151507, 105883, 105914, 151238, 151640, 152163, 151623, 151627, 151443, 151479, 152200, 152192, 151933, 152126, 152115, 152116, 151422, 152123, 151954, 105992, 105950, 151955, 152365, 151014, 151722, 151724, 151779, 151051, 151632, 105644, 152091, 105960, 151810, 151467, 151678, 151514, 151791, 152176, 152064, 151962, 151848, 151849, 151173, 151216, 151430, 151931, 105567, 105744, 105984, 151412, 151616, 151867, 151141, 151228, 152177, 151433, 151611, 152008, 105728, 151151, 105561, 151714, 105646, 152023, 105773, 105587, 105890, 151653, 151785, 151892, 152223, 152352, 152353, 152359, 152362, 151763, 151076, 151515, 105828, 151704, 151765, 151325, 151861, 151035, 151059, 105630, 151675, 105591, 105929, 151024, 151860, 152051, 152031, 105868, 105949, 151260, 151709, 151029, 105770, 105776, 105846, 105895, 151886, 151956, 151812, 151523, 105568, 105936, 105806, 151519, 152175, 152232, 152257, 151952, 151689, 151410, 151084, 105593, 151305, 151371, 105969, 151016, 151774, 152217, 152220, 151435, 105926, 151734, 105872, 151530, 105636, 151626, 151842, 151942, 151432, 151783, 151567, 151598, 151601, 151989, 151958, 151959, 151960, 151821, 151820, 105676, 151319, 151557, 151558, 151411, 151423, 105829, 105844, 151380, 151770, 151864, 105666, 151760, 105902, 105998, 105637, 151073, 151253, 151269, 151396, 151104, 105678, 105879, 105727, 105731, 105782, 105841, 151093, 151110, 151363, 151369, 151705, 152154, 151782, 151098, 151099, 151789, 105649, 151309, 152103, 152301, 151847, 105754, 105982, 151160, 151634, 151684, 151793, 151388, 151394, 105859, 151387, 151978, 152210, 152211, 151080, 152248, 151398, 152222, 151540, 151015, 152214, 151446, 105580, 151143, 152158, 151301, 152392, 105647, 105699, 105898, 151441, 105660, 151038, 151229, 105564, 105565, 152364, 105886, 151256, 151154, 151168, 151178, 151839, 151537, 151155, 151156, 151157, 151491, 105910, 152117, 105853, 105854, 105856, 151759, 151053, 151359, 105624, 151710, 152079, 152080, 105563, 105648, 105655, 151585, 105882, 151326, 151327, 151130, 151250, 151828, 151881, 151882, 105796, 105812, 151245, 152307, 152308, 152331, 105612, 151416, 151805, 152098, 151579, 151961, 105586, 151683, 151764, 105621, 151664, 151953, 105990, 151674, 105657, 101751, 152036, 151885, 105610, 151134, 151266, 151672, 151074, 151008, 151595, 152174, 151259, 151352, 152207, 151298
  • Clasificación del producto
    Radiology Devices
  • Distribución
    Nationwide and Puerto Rico
  • Descripción del producto
    Elekta Synergy || The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Dirección del fabricante
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    USFDA