Retiro De Equipo (Recall) de Device Recall 4D Integrated Treatment Console (4DITC)

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 Varian Medical Systems, Inc. Oncology Systems.

¿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
    59351
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3100-2011
  • Fecha de inicio del evento
    2011-06-27
  • Fecha de publicación del evento
    2011-08-30
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2013-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    In certain configurations, the 4ditc can interpret a rapidarc or vmat treatment field as 3d conformal arc treatment plan. if a rapidarc or vmat treatment field is incorrectly interpreted as conformal arc, the field will be delivered with a constant dose rate and gantry speed for the entire duration of the delivery, which can lead to delivered dose being different than planned.
  • Acción
    Varian sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated June 27, 2011 to all affected customers. The letter identified the product, problem and recommended user actions to follow. Customers were instructed to notify all appropriate personnel of the correction notice. The letter states that Varian Service will contact customers to arrange to perform update to 4D Integrated Treatment Console (4DITC) software. For further clarification, contact your local Varian Customer Support District or Regional Manager. The letter also provides Varian Oncology Help desk contact information 1-888-827-4265 for USA and Canada and +41417498844 for Europe.

Device

  • Modelo / Serial
    H510015, H511960, H513012, H513971, H514364, H514613, H514915, H515118, H515267, H515410, H515634, H510074, H511996, H513039, H513973, H514366, H514614, H514919, H515121, H515270, H515412, H515641, H510171, H512014, H513046, H513978, H514367, H514615, H514920, H515123, H515275, H515413, H515644, H510285, H512048, H513054, H513990, H514375, H514617, H514927, H515127, H515278, H515416, H515653, H510457, H512049, H513069, H513999, H514378, H514620, H514932, H515129, H515280, H515417, H515669, H510494, H512078, H513095, H514006, H514387, H514624, H514933, H515130, H515282, H515420, H515676, H510565, H512090, H513125, H514015, H514392, H514625, H514937, H515132, H515283, H515424, H515680, H510610, H512133, H513195, H514020, H514394, H514626, H514948, H515134, H515284, H515427, H515686, H510683, H512134, H513200, H514028, H514401, H514629, H514949, H515135, H515285, H515428, H515690, H510686, H512137, H513224, H514048, H514406, H514634, H514952, H515138, H515286, H515430, H515691, H510783, H512169, H513229, H514060, H514410, H514641, H514953, H515142, H515288, H515432, H515692, H510785, H512259, H513242, H514064, H514413, H514642, H514970, H515143, H515295, H515433, H515698, H510822, H512260, H513246, H514079, H514437, H514643, H515004, H515144, H515297, H515439, H515703, H510823, H512264, H513254, H514084, H514438, H514644, H515009, H515145, H515300, H515442, H515705, H510834, H512266, H513261, H514096, H514456, H514648, H515011, H515147, H515303, H515443, H515713, H510852, H512274, H513277, H514097, H514460, H514653, H515013, H515148, H515304, H515445, H515714, H510863, H512283, H513279, H514100, H514469, H514660, H515014, H515150, H515306, H515447, H515716, H510889, H512345, H513301, H514101, H514474, H514662, H515017, H515151, H515310, H515451, H515723, H510920, H512436, H513306, H514112, H514481, H514670, H515018, H515152, H515314, H515455, H515730, H511043, H512471, H513341, H514114, H514482, H514672, H515019, H515158, H515315, H515461, H515732, H511064, H512492, H513362, H514122, H514483, H514675, H515020, H515161, H515318, H515462, H515740, H511066, H512495, H513405, H514146, H514486, H514677, H515021, H515162, H515320, H515463, H515742, H511073, H512498, H513433, H514161, H514488, H514678, H515024, H515169, H515321, H515467, H515743, H511130, H512511, H513450, H514173, H514489, H514682, H515027, H515171, H515322, H515472, H515771, H511132, H512536, H513471, H514185, H514494, H514683, H515033, H515173, H515323, H515474, H515778, H511149, H512537, H513498, H514186, H514497, H514689, H515034, H515174, H515325, H515475, H515796, H511152, H512539, H513499, H514187, H514499, H514691, H515038, H515175, H515327, H515478, H515809, H511153, H512573, H513510, H514192, H514506, H514692, H515039, H515178, H515328, H515480, H515810, H511166, H512576, H513525, H514198, H514514, H514702, H515046, H515179, H515332, H515482, H515811, H511202, H512578, H513542, H514216, H514515, H514711, H515049, H515181, H515336, H515487, H515813, H511285, H512579, H513545, H514219, H514516, H514716, H515050, H515184, H515337, H515490, H515819, H511286, H512600, H513551, H514227, H514517, H514732, H515056, H515189, H515339, H515491, H515820, H511322, H512602, H513554, H514236, H514520, H514752, H515059, H515196, H515340, H515492, H515840, H511326, H512621, H513604, H514237, H514521, H514759, H515060, H515197, H515342, H515494, H515846, H511361, H512647, H513645, H514238, H514523, H514763, H515061, H515198, H515346, H515501, H515879, H511364, H512652, H513646, H514241, H514530, H514768, H515063, H515200, H515353, H515506, H515888, H511398, H512676, H513650, H514250, H514534, H514769, H515064, H515205, H515354, H515507, H515902, H511412, H512677, H513691, H514262, H514540, H514781, H515070, H515208, H515355, H515510, H515947, H511434, H512678, H513697, H514265, H514541, H514782, H515071, H515210, H515358, H515511, H515979, H511491, H512679, H513741, H514268, H514546, H514783, H515072, H515211, H515362, H515514, H515983, H511504, H512680, H513742, H514285, H514555, H514794, H515073, H515212, H515363, H515515, H516012, H511538, H512681, H513749, H514288, H514556, H514804, H515075, H515213, H515366, H515516, H518171, H511551, H512695, H513761, H514289, H514560, H514805, H515078, H515214, H515373, H515523, H518187, H511554, H512713, H513766, H514291, H514561, H514812, H515082, H515215, H515376, H515527, H518200, H511584, H512758, H513783, H514306, H514572, H514817, H515086, H515218, H515379, H515529, H51B031, H511656, H512774, H513790, H514316, H514574, H514820, H515088, H515224, H515380, H515531, H511673, H512783, H513802, H514329, H514575, H514821, H515090, H515225, H515381, H515534, H511698, H512786, H513805, H514331, H514578, H514824, H515091, H515227, H515382, H515535, H511707, H512787, H513826, H514332, H514579, H514826, H515092, H515232, H515384, H515536, H511745, H512813, H513841, H514337, H514580, H514827, H515097, H515238, H515385, H515538, H511765, H512819, H513842, H514342, H514581, H514843, H515099, H515242, H515387, H515539, H511800, H512822, H513845, H514343, H514584, H514851, H515100, H515246, H515394, H515547, H511806, H512831, H513860, H514345, H514596, H514855, H515101, H515252, H515398, H515552, H511845, H512888, H513863, H514346, H514602, H514856, H515105, H515257, H515399, H515562, H511916, H512929, H513873, H514348, H514603, H514857, H515107, H515258, H515400, H515566, H511917, H512966, H513911, H514349, H514604, H514863, H515108, H515260, H515403, H515596, H511932, H512967, H513912, H514350, H514605, H514875, H515110, H515262, H515405, H515604, H511937, H512992, H513944, H514357, H514608, H514876, H515115, H515263, H515407, H515613, H511951, H512995, H513952, H514359, H514609, H514895, H515116, H515264, H515408, H515623, H511959, H513004, H513955, H514362, H514612, H514905, H515117, H515265, H515409, H515628A
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide)
  • Descripción del producto
    Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc Treatment Plan as a 3D Conformal Arc Treatment Plan; version v8.6 or 8.8 in combination with treatment planning systems; Model Number: H51; Reference/PSCA Identifier: CP-03063; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || Product Usage: 4D Integrated treatment console is designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA