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
    102567
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2005-09-20
  • 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
    If symmetric field moded up when non-varian linac positions are asymmetric & linac x1/y1 jaw value=1/2 plan symmetric value then x2/y2 jaw value out of position. treatment will not be inhibited.

Device

VARIS TREATMENT
  • Modelo / Serial
    Model Catalog: TREATMENT (Lot serial: H462022); Model Catalog: TREATMENT (Lot serial: H462023); Model Catalog: TREATMENT (Lot serial: H462024); Model Catalog: TREATMENT (Lot serial: H462086); Model Catalog: TREATMENT (Lot serial: H462059); Model Catalog: TREATMENT (Lot serial: H462052); Model Catalog: TREATMENT (Lot serial: H462051); Model Catalog: TREATMENT (Lot serial: H462050); Model Catalog: TREATMENT (Lot serial: H462047); Model Catalog: TREATMENT (Lot serial: H462029); Model Catalog: TREATMENT (Lot serial: H462028); Model Catalog: TREATMENT (Lot serial: H462021); Model Catalog: TREATMENT (Lot serial: H462027); Model Catalog: TREATMENT (Lot serial: H462019); Model Catalog: TREATMENT (Lot serial: H462018); Model Catalog: TREATMENT (Lot serial: H462017); Model Catalog: TREATMENT (Lot serial: H462016); Model Catalog: TREATMENT (Lot serial: H460100); Model Catalog: TREATMENT (Lot serial: H462087); Model Catalog: TREATMENT (Lot serial: H462020)
  • Descripción del producto
    Vision Treatment/EVI RTP Exchange v6.6
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.