Events

Retiro De Equipo (Recall) de BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHILIPS ELECTRONICS LTD..

¿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
    32304
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2018-01-05
  • 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
    Philips became aware of issues with brilliance big bore ct systems running software version 4.2.0. the most significant issues are: issue #1: efov (extended field of view) check message does not display when fov is set >600mm for a paused scan issue #2: prefer "center x/y 0" and "disable result rotation" checkboxes checked automatically when checking the "ct simulation" issue #3: tumor loc allows poi (point of interest) locking when a non-isocenter slice is displayed issue #4: tracker scan completed no images were generated issue #5: continuous link plans the clinical scan outside the surview issue #6: applying tilt on first mpr result when the other axial results are unplanned causes change in scan length and number of cycles of scan issue #7: "system is still initializing. please wait." error issue #8: auto locations not functioning as expected issue #9: system ended exam before completion issue #10: system freeze-up after pause is pressed (for french translation please see e-file).

Device

BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: 728244 (Lot serial: N/A)
  • Descripción del producto
    BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    HC