Events

Retiro De Equipo (Recall) de True Beam

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
    61693
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1495-2012
  • Fecha de inicio del evento
    2012-04-09
  • Fecha de publicación del evento
    2012-05-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108734
  • 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
    A software anomaly has been identified in truebeam when using respiratory gating with patients in the prone position. the gating curve is inverted when a prone patient plan is loaded into truebeam.
  • Acción
    Varian sent an Urgent Medical Device Correction - Urgent Field Safety Notice dated April 13, 2012 to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the affected product, description of problem, details and recommended user actions. Varian will provide a software version that will mitigate the issue described in the letter and Varian Customer Support will notify each affected facility when the software is available. The letter instructs customers to retained a copy of this notice along with the most current product labeling. For future reference, this document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. For questions contact Varian Oncology Help Desk at 1-888-827-4265 US and Canada.

Device

True Beam
  • Modelo / Serial
    Model number H19; serial numbers: H191001 H191061 H191121 H191180 H191002 H191063 H191122 H191181 H191003 H191064 H191123 H191182 H191005 H191065 H191124 H191183 H191006 H191066 H191125 H191184 H191007 H191067 H191126 H191185 H191008 H191068 H191127 H191186 H191009 H191069 H191128 H191187 H191010 H191070 H191129 H191188 H191011 H191071 H191130 H191189 H191012 H191072 H191131 H191190 H191013 H191073 H191132 H191191 H191014 H191074 H191133 H191192 H191015 H191076 H191134 H191194 H191016 H191077 H191135 H191195 H191017 H191078 H191136 H191197 H191018 H191079 H191137 H191198 H191019 H191080 H191138 H191199 H191020 H191081 H191139 H191201 H191021 H191082 H191140 H191202 H191022 H191083 H191141 H191203 H191023 H191084 H191142 H191205 H191024 H191085 H191143 H191206 H191025 H191086 H191144 H191207 H191026 H191087 H191145 H191209 H191027 H191088 H191146 H191210 H191028 H191089 H191147 H191213 H191029 H191090 H191148 H191215 H191030 H191091 H191149 H191221 H191031 H191092 H191150 H191225 H191032 H191093 H191151 H191226 H191033 H191094 H191152 H191227 H191034 H191095 H191153 H191228 H191035 H191096 H191154  H191036 H191097 H191155  H191037 H191098 H191156  H191038 H191099 H191157  H191039 H191100 H191158  H191040 H191101 H191159  H191041 H191102 H191160  H191042 H191103 H191161  H191043 H191104 H191162  H191044 H191105 H191163  H191045 H191106 H191164  H191046 H191107 H191165  H191047 H191108 H191166  H191048 H191109 H191167  H191049 H191110 H191168  H191051 H191111 H191169  H191052 H191112 H191170  H191053 H191113 H191171  H191054 H191114 H191172  H191055 H191115 H191174  H191056 H191116 H191175  H191057 H191117 H191176  H191058 H191118 H191177  H191059 H191119 H191178  H191060 H191120 H191179  ***AMENDED INFO***: H191208, H191211, H191214, H191217, H191219, H191220, H191222, H191223, H191224***
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide and the countries ofAustralia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom
  • Descripción del producto
    True Beam; || Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below. || Varian Medical Systems, || Palo Alto, CA. || Product Usage: || TrueBeam Radiotherapy delivery system is intended to provide sterotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
  • 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