Events

Retiro De Equipo (Recall) de VARIAN TREATMENT FOR MULTIVENDOR LINACS

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
    86885
  • 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
    An anomaly has been identified with varian treatment apploication failing to load a physical wedge filter for a treatment field delivered on a siemens mevatron linear accelerator. after a plan with wedge field is opened on varian treatment users may not observe that a wedge filter may actually be missing from one or more fields without any notification from the treatment application. the user may come to understand that the wedge filter was missing only after the treatment field had been partially or completely delivered. when the user attempts to close the patient session from the treatment application. in this situation the treatment application forces the user to unload the patient session requires user authorization and informs the user that the treatment record for the missing wedge field(s) cannot be saved to varian's oncology information system (ois). delivery of a treatment field without the planned wedge filter could result in an over dosage for that beam and potentially an unintended dose uniformity of the target treatment volume. this anomaly is intermittent and may occur infrequently. this issue could occur with a siemens elekta or ge system that has physical wedges.

Device

VARIAN TREATMENT FOR MULTIVENDOR LINACS
  • Modelo / Serial
    Model Catalog: 100042022 (Lot serial: H466051); Model Catalog: 100042022 (Lot serial: H466052); Model Catalog: 100042022 (Lot serial: H466053); Model Catalog: 100042022 (Lot serial: H466050); Model Catalog: 100042022 (Lot serial: H462051); Model Catalog: 100042022 (Lot serial: H462050)
  • Descripción del producto
    Varian Treatment For Multivendor Linacs
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.