Events

Retiro De Equipo (Recall) de Device Recall Optical Guidance Platform, version 2.6 and 2.6.1

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
    58252
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2176-2011
  • Fecha de inicio del evento
    2011-03-03
  • Fecha de publicación del evento
    2011-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98818
  • 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
    The anomaly that has been identified with the optical guidance platform (ogp) software may not be always displaying the correct transfer date on the patient file.
  • Acción
    The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" letter dated March 3, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the Optical Guidance Platform (OGP) Instructions For Use on Loading a treatment plan; before positioning the patient, compare the plan details loaded into the OGP with the plan details printed from the treatment planning systems; verify that the patient information, isocenter, gantry and couch angles are identical as requested in the Instructions For Use, and advise the appropriate personnel working in their radiotherapy department of the content of this recall letter. Varian has made changes to the OGP Instructions For Use -Varian strongly recommends you download the most recent version at www.MyVarian.com or request a copy from your local Varian Customer Support District or Regional Manager. Varian also is preparing a software correction which will be applied to affected unites to correct this issue. If you require further clarification, please feel free to contact your local Varian Customer Support District or Regional Manager at the follow: USA and Canada - 1-888-827-4265; Europe +41 41 749 8844; E-mail-North America: support-americas@varian.com; Australia/New Zealand: support.anz@varian.com; Europe: support-emca@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: china.apps.helpdesk@varian.com; Japan: Japan.Apps.Helpdesk@varian.com, and Latin America: soporte.al@varian.com; Internet: Oncology Systems customer site - www.myvarian.com and Varian Medical Systems public site-www.varian.com.

Device

Device Recall Optical Guidance Platform, version 2.6 and 2.6.1
  • Modelo / Serial
    HZ10003 HZ10151 HZ10305 HZ10507 HZ10670 HZ11015 HZ12040  HZ12090 HZ13050 HZ17041 HZ18062  HZ10008 HZ10153 HZ10311 HZ10508 HZ10674 HZ11016 HZ12041  HZ12091 HZ13052 HZ17042 HZ18066  HZ10013 HZ10154 HZ10313 HZ10509 HZ10675 HZ11017 HZ12042  HZ12092 HZ13053 HZ17043 HZ18068  HZ10014 HZ10155 HZ10316 HZ10513 HZ10676 HZ11018 HZ12043  HZ12093 HZ13054 HZ17044 HZ18069  HZ10015 HZ10157 HZ10326 HZ10528 HZ10679 HZ11019 HZ12044  HZ12094 HZ13055 HZ17046 HZ18070  HZ10017 HZ10159 HZ10330 HZ10534 HZ10681 HZ11020 HZ12045  HZ12095 HZ13056 HZ17048 HZ18076  HZ10019 HZ10165 HZ10333 HZ10537 HZ10684 HZ11021 HZ12046  HZ12096 HZ13057 HZ17049 HZ18077  HZ10023 HZ10170 HZ10335 HZ10540 HZ10685 HZ11022 HZ12047  HZ12097 HZ13058 HZ17051 HZ18079  HZ10024 HZ10172 HZ10337 HZ10541 HZ10689 HZ11023 HZ12048  HZ12098 HZ13059 HZ17057 HZ18085  HZ10025 HZ10179 HZ10343 HZ10542 HZ10693 HZ11024 HZ12049  HZ12099 HZ13060 HZ17058 HZ18088  HZ10026 HZ10181 HZ10347 HZ10544 HZ10698 HZ11025 HZ12050  HZ12100 HZ13062 HZ17059 HZ18118  HZ10027 HZ10182 HZ10352 HZ10545 HZ10700 HZ12001 HZ12051  HZ12101 HZ13063 HZ17061 HZ18120  HZ10029 HZ10183 HZ10357 HZ10547 HZ10703 HZ12002 HZ12052   HZ12102 HZ13064 HZ17062 HZ18126  HZ10044 HZ10185 HZ10368 HZ10552 HZ10706 HZ12003 HZ12054  HZ12103 HZ15006 HZ17065 HZ18131  HZ10046 HZ10187 HZ10372 HZ10553 HZ10712 HZ12004 HZ12056   HZ12104 HZ15070 HZ17067 HZ18132  HZ10048 HZ10188 HZ10376 HZ10557 HZ10715 HZ12005 HZ12057  HZ12107 HZ15118 HZ17068 HZ18134  HZ10051 HZ10190 HZ10378 HZ10560 HZ10717 HZ12006 HZ12058  HZ12108 HZ15480 HZ17069 HZ18142  HZ10052 HZ10194 HZ10379 HZ10562 HZ10722 HZ12007 HZ12059  HZ12125 HZ16006 HZ17070 HZ18143  HZ10054 HZ10196 HZ10387 HZ10568 HZ10724 HZ12008 HZ12060  HZ12126 HZ16069 HZ17071 HZ18155  HZ10055 HZ10201 HZ10392 HZ10580 HZ10728 HZ12009 HZ12061  HZ12154 HZ16070 HZ17072 HZ18175  HZ10058 HZ10203 HZ10394 HZ10584 HZ10730 HZ12010 HZ12062  HZ12188 HZ17001 HZ17074 HZ18188  HZ10061 HZ10205 HZ10398 HZ10591 HZ10731 HZ12011 HZ12063  HZ12190 HZ17002 HZ17078 HZ18193  HZ10063 HZ10209 HZ10401 HZ10592 HZ10733 HZ12012 HZ12064  HZ13006 HZ17003 HZ17079 HZ19001  HZ10065 HZ10210 HZ10403 HZ10594 HZ10737 HZ12013 HZ12065  HZ13009 HZ17006 HZ17081 HZ19003  HZ10068 HZ10220 HZ10404 HZ10598 HZ10740 HZ12015 HZ12066   HZ13013 HZ17007 HZ17106 HZ19004  HZ10070 HZ10228 HZ10408 HZ10601 HZ10743 HZ12016 HZ12067   HZ13019 HZ17010 HZ17118 HZ19005  HZ10073 HZ10237 HZ10409 HZ10607 HZ10744 HZ12018 HZ12068   HZ13020 HZ17011 HZ17126 HZ19006  HZ10076 HZ10239 HZ10411 HZ10609 HZ10759 HZ12019 HZ12069   HZ13021 HZ17012 HZ17137 HZ19007  HZ10083 HZ10240 HZ10412 HZ10611 HZ10762 HZ12020 HZ12070   HZ13022 HZ17013 HZ17142 HZ19010  HZ10084 HZ10242 HZ10425 HZ10612 HZ10764 HZ12021 HZ12071   HZ13023 HZ17016 HZ17175 HZ19012  HZ10086 HZ10245 HZ10426 HZ10613 HZ10766 HZ12022 HZ12072  HZ13024 HZ17017 HZ18001 HZ19013  HZ10088 HZ10247 HZ10430 HZ10617 HZ10771 HZ12023 HZ12073   HZ13026 HZ17018 HZ18002 HZ19014  HZ10090 HZ10249 HZ10434 HZ10620 HZ10774 HZ12024 HZ12074   HZ13029 HZ17019 HZ18004 HZ19015  HZ10092 HZ10254 HZ10438 HZ10627 HZ10776 HZ12026 HZ12075  HZ13030 HZ17020 HZ18006 HZ19017  HZ10095 HZ10257 HZ10442 HZ10629 HZ10778 HZ12027 HZ12076  HZ13031 HZ17021 HZ18013 HZ19018  HZ10098 HZ10258 HZ10450 HZ10632 HZ11001 HZ12028 HZ12077   HZ13032 HZ17023 HZ18018 HZ19019  HZ10102 HZ10260 HZ10453 HZ10640 HZ11002 HZ12029 HZ12078  HZ13038 HZ17024 HZ18020 HZ19020  HZ10108 HZ10271 HZ10460 HZ10644 HZ11003 HZ12030 HZ12080   HZ13039 HZ17027 HZ18022 HZ19022  HZ10110 HZ10273 HZ10467 HZ10646 HZ11004 HZ12031 HZ12081  HZ13041 HZ17028 HZ18024 HZ19023  HZ10116 HZ10274 HZ10479 HZ10647 HZ11005 HZ12032 HZ12082   HZ13042 HZ17030 HZ18026 HZ19025  HZ10117 HZ10283 HZ10489 HZ10649 HZ11006 HZ12033 HZ12083  HZ13043 HZ17032 HZ18035 HZ19026  HZ10121 HZ10293 HZ10493 HZ10650 HZ11007 HZ12034 HZ12084   HZ13044 HZ17034 HZ18040 HZ19028  HZ10126 HZ10294 HZ10495 HZ10652 HZ11008 HZ12035 HZ12085   HZ13045 HZ17035 HZ18041 HZ19029  HZ10138 HZ10295 HZ10496 HZ10656 HZ11010 HZ12036 HZ12086   HZ13046 HZ17036 HZ18042 HZ19033  HZ10144 HZ10297 HZ10497 HZ10659 HZ11011 HZ12037 HZ12087   HZ13047 HZ17037 HZ18043 HZ19034  HZ10146 HZ10299 HZ10500 HZ10663 HZ11013 HZ12038 HZ12088   HZ13048 HZ17039 HZ18046 HZ19035  HZ10148 HZ10303 HZ10501 HZ10665 HZ11014 HZ12039 HZ12089  HZ13049 HZ17040 HZ18048 HZ19036  HZ19040 HZ19041 HZ19043 HZ19044 HZ19045 HZ19046 HZ19051   HZ19052 HZ19053 HZ19055 HZ19056  HZ19059 HZ19060 HZ19062 HZ19065 HZ19066 HZ19068 HZ19069  HZ19071 HZ19072 HZ19076 HZ19078  HZ19079 HZ19086 HZ19087 HZ19088 HZ19089 HZ19091 HZ19095  HZ19096 HZ19098 HZ19099 HZ19104  HZ19106 HZ19109 HZ19113 HZ19114 HZ19115 HZ19117 HZ19118  HZ19119 HZ19121 HZ19125 HZ19126  HZ19128 HZ19129 HZ19130 HZ19131 HZ19133 HZ19134 HZ19135   HZ19140 HZ19141 HZ19142 HZ19143  HZ19155 HZ19158 HZ19159 HZ19162 HZ19167 HZ19170 HZ19171  HZ19172 HZ19179 HZ19186 HZ19189  HZ19190 HZ19193 HZ19194 HZ19195 HZ19201 HZ19226 HZ19227  HZ19228 HZ19229 HZ19235 HZ19236  HZ19611 HZ19926 HZ19996 HZ19997 HZ19998
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03976; Model Number: HZ1; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

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