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
    94139
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-17
  • 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
    When multiple conical collimator treatment plans are scheduled to be treated in a session the plan label should be displayed on the bccv dialog box should match the plan label on the 4ditc. however the name of the plan is not being updated correctly. all other identifiers including the accessory mount (conical collimator) are correct and are displayed correctly. a report was received involving the 4d integrated treatment console (4ditc) and bar - code conical collimator (bccv) indicating that the plan label is not updated correctly in bccv display if multiple plans are open in 4ditc simulatenously.

Device

ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Modelo / Serial
    Model Catalog: V8.8 (Lot serial: H513769); Model Catalog: BCCV (Lot serial: HBC0210); Model Catalog: BCCV (Lot serial: HBC0028); Model Catalog: V8.8 (Lot serial: H515461)
  • Descripción del producto
    ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.