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
    124507
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-09-17
  • 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
    Issue 1: image position accuracy - image rotation calibration program performed by field service representative can report pass but fail to produce the correct angular rotation offset value for the ultra-fast scan mode. the inaccurate angular rotation offset can impact the accuracy of radiation treatment planning. issue 2: tracker image artifact - tracker scan image of ct angiography (cta) examination can exhibit a streaking artifact. due to the streaking artifact the automatic clinical scan may be triggered at the wrong time resulting in suboptimal ct diagnostic images that do not capture the bolus peak of the imaged body section. issue 3: ring/dot image artifact due to x-ray measurement - after a complete system power shutdown and power up if a head scan is performed without air calibration and without quick iq check scan after power up intermittent ring/dot image artifacts in the reconstructed images may occur.

Device

BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: 4535 670 88051 (Lot serial: ALL); Model Catalog: 728323 (Lot serial: ALL)
  • 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