Events

Retiro De Equipo (Recall) de VARIS TREATMENT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por VARIAN MEDICAL SYSTEMS INC..

¿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
    65263
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2008-11-22
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    A malfunction in varis software if undetected could result in an under dose of as much as 100%. commas used instead of decimals for numerical separators with this version 6.6.5042 are not understood properly.

Device

VARIS TREATMENT
  • Modelo / Serial
    Model Catalog: PRODUCT CODE: H46 (Lot serial: H462021); Model Catalog: VERSION 6.6.5042 6.6.504 (Lot serial: H462022); Model Catalog: PRODUCT CODE: H46 (Lot serial: H462022); Model Catalog: VERSION 6.6.5042 6.6.504 (Lot serial: H462023); Model Catalog: PRODUCT CODE: H46 (Lot serial: H462023); Model Catalog: VERSION 6.6.5042 6.6.504 (Lot serial: H462024); Model Catalog: PRODUCT CODE: H46 (Lot serial: H462024); Model Catalog: PRODUCT CODE: H46 (Lot serial: H462017); Model Catalog: VERSION 6.6.5042 6.6.504 (Lot serial: H462017); Model Catalog: PRODUCT CODE: H46 (Lot serial: H462016); Model Catalog: VERSION 6.6.5042 6.6.504 (Lot serial: H462016); Model Catalog: VERSION 6.6.5042 6.6.504 (Lot serial: H462021)
  • Descripción del producto
    Varian Medical Varis Treatment System
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.