Events

Retiro De Equipo (Recall) de TRUEBEAM (RADIOTHERAPY CONFIGURATION) - MAIN UNIT

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
    105845
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-16
  • 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
    The 4ditc ad-hoc imaging ciao (complete irradiated area outline) calculation results in a ciao shape that differs from the ciao calculated in ariachart eclipse offline review and on-board imager. the 4ditc algorithm adds dose for the control point at the field edge which should not be added according to the system specifications. this error will be present in the 4ditc mlc display. the discrepancy is a display issue that is only seen when an ad-hoc image template has been added after the plan has been loaded on the 4ditc. if the 4ditc generated ciao image is projected on the patient using the light field the incorrect field edge will be displayed. if the field edge is used to set-up another abutting treatment field the area between the projected field edge and the abutting field edge would be mismatched and not treated.

Device

TRUEBEAM (RADIOTHERAPY CONFIGURATION) - MAIN UNIT
  • Modelo / Serial
    Model Catalog: TRUEBEAM (Lot serial: H191044); Model Catalog: TRUEBEAM (Lot serial: H191069); Model Catalog: TRUEBEAM (Lot serial: H191071); Model Catalog: TRUEBEAM (Lot serial: H191038); Model Catalog: TRUEBEAM (Lot serial: H191074); Model Catalog: V8.8 (Lot serial: CONTACT MANUFACTURER.); 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: V8.1.2 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: V8.1.2 (Lot serial: >10 SERIAL NUMBERS.)
  • Descripción del producto
    TRUEBEAM (RADIOTHERAPY CONFIGURATION) - MAIN UNIT
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.