Events

Recall of Device Recall 4D Integrated Treatment Console (4DITC)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems, Inc. Oncology Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59351
  • Event Risk Class
    Class 2
  • Event Number
    Z-3100-2011
  • Event Initiated Date
    2011-06-27
  • Event Date Posted
    2011-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102343
  • Notes / Alerts
    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.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • Reason
    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)
  • Model / 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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Product Description
    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
  • Manufacturer Address
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA