Events

Rappel de Varian

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.

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
    45520
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0544-2008
  • Date de mise en oeuvre de l'événement
    2007-09-10
  • Date de publication de l'événement
    2008-02-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-11-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65723
  • 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
    Linear Accelerator - Product Code IYE
  • Cause
    Treatment error: the collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.
  • Action
    On 9/10/07, the firm issued an Urgent Medical Device Correction letter to all its direct consignees, informing them of the device defect and providing instructions on the recall. Short term user instructions were provided and the firm will schedule follow-up visits to make the needed permanent device corrections at each device site.

Device

Varian
  • Modèle / numéro de série
    The Serial Numbers: H271306; including: H140010, H140046, H140047, H140060, H140095, H140098, H140120, H140124, H140130, H140143, H140144, H140145, H140148, H140152, H140201, H140202, H140203, H140204, H140208, H140209, H140210, H140211, H140213, H140214, H140217, H140218, H140220, H140221, H140223, H140224, H140225, H140226, H140227, H140229, H140233, H140235, H140237, H140703, H140706, H140715, H140716, H140721, H140723, H140725, H140727, H140728, H140731, H140735, H140742,  H270144, H270357, H270412, H270423, H270518, H270608, H270615, H270618, H270680, H270707, H270750, H270792, H270811, H270845, H270862, H270885, H270890, H270893, H271013, H271023, H271031, H271049, H271112, H271113, H271118, H271122, H271154, H271169, H271224, H271275, H271333, H271341, H271345, H271358, H271365, H271413, H271444, H271602, H271673, H271790, H271852, H271879, H271890, H271893, H271906, H271940, H271962, H271964, H271977, H271999, H272023, H272061, H272105, H272108, H272148, H272153, H272184, H272203, H272230, H272241, H272242, H272273, H272319, H272320, H272360, H272375, H272380, H272437, H272452, H272494, H272804, H272822, H272854, H272856, H272892, H272929, H272931, H272982, H273001, H273007, H273019, H273042, H273086, H273120, H273123, H273127, H273132, H273136, H273137, H273146, H273157, H273165, H273180, H273189, H273190, H273197, H273209,  H290106, H290107, H290142, H290165, H290176, H290179 , H290186, H290201, H290203, H290205, H290206, H290213, H290215, H290236, H290244, H290254, H290259, H290326, H290358, H290404, H290503, H290504, H290508, H290512, H290517, H290519, H290520, H290535, H290548, H291002, H291005, H291008, H291012, H291014, H291017, H291018, H291023, H291024, H291025, H291033, H291036, H291037, H291043, H291046, H291047, H291050, H291053, H291056, H291059, H291062, H291064, H291069, H291070, H291071, H291073, H291082, H291083, H291084, H291086, H291087, H291091, H291094, H291095, H291096, H291099, H291108, H291109, H291112, H291113, H291117, H291119, H291121, H291127, H291128, H291129, H291130, H291133, H291135, H291140, H291141, H291144, H291150, H291158, H291163, H291164, H291165, H291166, H291167, H291168, H291169, H291170, H291171, H291172, H291174, H291178, H291179, H291181, H291182, H291185, H291193, H291196, H291200, H291203, H291204, H291205, H291206, H291208, H291209, H291211, H291214, H291216, H291217, H291218, H291220, H291223, H291224, H291231, H291237, H291238, H291241, H291247, H291248, H291250, H291251, H291254, H291255, H291256, H291264, H291265, H291269, H291270, H291272, H293303, H293311, H293313, H293319, H293330, H293331, H293335, H293342, H293344, H293346, H293348, H293355, H293356, H293360, H293367, H293385, H293394, H293395, H293397, H293398, H293400, H293401, H293404, H293405, H293406, H293410, H293414, H293416, H293417, H293418, H293423, H293425, H293426, H293437, H293438, H293439, H293441, H293447, H293449, H293451, H293452, H293456, H293457, H293458, H293466, H293470, H293475, H293476, H293477, H293478, H293479, H293480, H293481, H293483, H293484, H293488, H293490, H293502, H293505, H293509, H293515, H293516, H293517, H293518, H293525, H293531, H293537, H293541, H293543, H293544, H293546, H293557, H293558, H293560, H293561, H293562, H293565, H293572, H293581, H293583, H293593, H293596, H293598, H293599, H293614, H293627, H293630, H293635, and H293642
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide- Canada, Mexico, and the USA
  • Description du dispositif
    Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High Energy Clinacs with one or more of the following options: || -- BrainLAB micro MLC, || -- 6MV SRS photon beam, || -- Fine Beam Isocenter Accuracy, || -- Stereotactic motion disable. || ----Product is manufactured and distributed by Varian Medical Systems, Palo Alto, CA
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc
  • Adresse du fabricant
    Varian Medical Systems Inc, 911 Hansen Way, Palo Alto CA 94304
  • Source
    USFDA