Events

Retiro De Equipo (Recall) de ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)

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
    42986
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-06-29
  • 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
    Under certain specific circumstances the gantry rotates in the opposite direction to that specified according to the plan parameters when moving from one field to the next. if the patient couch or other medical equipment isi n the path of the gantry damage to property or injury to a patient could occur. according to varian iec scale the gantry will rotate clockwise (cw) from 0.0 degrees to 180.0 degrees and counterclockwise from 0.0 degrees to 180.0e degrees. by default when a user creates an opposing field within a plan that contains static fields the gantry rotation is set to rotate in the clockwise direction. for situations when that is not desired a user activated extended angle flag is provided to cause the gantry to rotate in a counterclockwise direction.

Device

ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Modelo / Serial
    Model Catalog: V8.8 (Lot serial: >10 Serial numbers.); Model Catalog: V8.6 (Lot serial: >10 Serial numbers.); Model Catalog: V8.1.2 (Lot serial: >10 Serial numbers.); Model Catalog: V8.8 (Lot serial: Contact manufacturer.); Model Catalog: V8.6 (Lot serial: Contact manufacturer.); Model Catalog: V8.1.2 (Lot serial: Contact manufacturer.)
  • Descripción del producto
    Aria Practice Management - 4D Integrated Treatment Console (4DITC)
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.