Events

Rappel de Device Recall 4D Integrated Treatment Console (4DITC)

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 Varian Medical Systems, Inc. Oncology Systems.

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
    59351
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3100-2011
  • Date de mise en oeuvre de l'événement
    2011-06-27
  • Date de publication de l'événement
    2011-08-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102343
  • 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
    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.
  • Action
    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

Device Recall 4D Integrated Treatment Console (4DITC)
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Description du dispositif
    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
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Adresse du fabricant
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Société-mère du fabricant (2017)
    Varian Medical Systems Inc
  • Source
    USFDA