Events

Retiro De Equipo (Recall) de INGENIA 3.0T CX

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
    16504
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-10-17
  • 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
    The thickness and location of the shielding material must be installed according to the shielding requirements provided by philips. in cases where the requirements are not followed the distance between the passive shielding rear wall and the magnet could be insufficient. an insufficient distance leads to stronger attraction forces between the magnet and the passive shielding. these stronger forces may lead to shearing of the magnet vibration pads. in a worst case scenario it may result in displacement of the magnet. displacement of a magnet can result in image quality issues and mechanical fitting problems with the table. these functional issues affect the clinical usage of the mr system.

Device

INGENIA 3.0T CX
  • Modelo / Serial
    Model Catalog: 781271 (Lot serial: 78012); Model Catalog: ACHIEVA XR (Lot serial: 35062); Model Catalog: ACHIEVA 3.0T (Lot serial: 38195); Model Catalog: ACHIEVA 3.0T (Lot serial: 38109); Model Catalog: 3.0T (Lot serial: 71068); Model Catalog: 3.0T (Lot serial: 71300); Model Catalog: 3.0T (Lot serial: 71481); Model Catalog: 3.0T (Lot serial: 71081)
  • Descripción del producto
    INGENIA 3.0T CX;ACHIEVA XR SYSTEM - MAIN UNIT;ACHIEVA 3.0T MRI SYSTEM - MAIN UNIT;INGENIA 3.0T
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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