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
    86960
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-03
  • 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
    It has been identified that in certain configurations the 4ditc can interpret a rapidarc or vmat treatment field as 3d conformal arc treatment plan. if a rapidarc or vmat treatment field is incorrectly interpreted as conformal arc the field will be delivered with a constant dose rate and gantry speed for the entire duration of the delivery which can lead to delivered dose being different than planned. this will only happen when the change in mu / deg between consecutive control points is small. in other words it can only happen when the dose rate or gantry speeds vary in a very smooth and progressive way for the entire rapidarc field. rapidarc treatment plans created with eclipse 8.2 and higher or potentially vmat treatment plans created with 3rd party treatment planning systems when delivered on the 4ditc v8.6 and v8.8 can be incorrectly identified as 3d conformal arc treatment plan.

Device

ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Modelo / Serial
    Model Catalog: V8.6 (Lot serial: >10 serial numbers.); Model Catalog: V8.8 (Lot serial: >10 serial numbers.); Model Catalog: V8.6 (Lot serial: Contact manufacturer.); Model Catalog: V8.8 (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.