Events

Retiro De Equipo (Recall) de INTELLISPACE PORTAL

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
    20539
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-07-30
  • 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
    There are software issues in the affected product. 1-when reopening a bookmark generated from processing a muga (multi-gated acquisition) scan within the nm cardiac application the ejection fraction (ef) may be different. 2-when processing using one of the following nm clinical applications: autoquant emory cardiac toolbox corridor4dm or neuroq the patient study presented to the reviewing physician within the application may be for a different patient than the one selected from the patient directory. note: the data presented to the reviewing physician is the data for the patient presented by the application labeling. 3-while using the nm viewer application an arrow annotation added to a display moves away from its original position if the viewer is subsequently maximized or if the image within the viewer is subsequently zoomed in or out. 4-while displaying pet images within ct viewer the suv results displayed may be calculated with an suv method different from the one specified in system preferences. this issue affects the ct viewer and multi-modality tumor tracking applications.

Device

INTELLISPACE PORTAL
  • Modelo / Serial
    Model Catalog: 4598 003 15411 (Lot serial: N/A); Model Catalog: 4598 003 56911 (Lot serial: N/A); Model Catalog: 4598 001 31111 (Lot serial: N/A); Model Catalog: 4598 001 30491 (Lot serial: N/A)
  • Descripción del producto
    INTELLISPACE PORTAL
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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