Events

Retiro De Equipo (Recall) de ECLIPSE TPS V8.8

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
    51437
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-18
  • 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
    In eclipse the model for linear accelerator treatment head consists of both upper and lower jaws with an optional mlc. in the case of a treatment machine where the mlc replaces the lower moveable jaws (eg. siemens mlc and ge mlc) the lower jaw and mlc is represented in eclipse by combination of virtual jaws and an mlc. the calculation will treat the virtual jaw as a beam limiting device such that the resultant dose distribution will be bounded by the virtual jaw if it lies within the mlc aperture. when calculating or approving a treatment plan if a virtual jaw is positioned inside the mlc aperture a warning will be displayed in external beam planning task when planning for siemens mlc accelerator. this warning states that the virtual collimator jaws are positioned inside the mlc aperture a position which is not physically possible. this warning message is not displayed in case of other accelerator types without back up jaws (eg. ge saturne with ge mlc) or when irreg planning task is being used. if the user proceeds with the calculation the virtual jaws will remain in the current position and will be handled as a beam limiting device for the dose calculation. this will result in the region under the virtual jaw but within the mlc aperture showing no or low dose. treatment using such a plan will result in dose being delivered to the patient outside of the area indicated in the planned dose distribution and within the entire mlc aperture.

Device

ECLIPSE TPS V8.8
  • Modelo / Serial
    Model Catalog: 100042024 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: TPA001075000 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: TPA001075000 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: 100042024 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: UP9001 (Lot serial: H481364); Model Catalog: UP9001 (Lot serial: H482173)
  • Descripción del producto
    Eclipse Treatment Planning System V8.8
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.