Events

Retiro De Equipo (Recall) de INTELLISPACE PORTAL HX

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
    85367
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-25
  • 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 has identified software and user issues with specific applications and options running on the intellispace portal (isp) with software version 4.0 or version 4.0.1 that if the issues were to re-occur it could pose a risk for the patient. software issues: 1. when the user chooses to launch different patient studies directly from the pacs archive into portal applications (pacs integration configuration) the system does not warn the user that a different patient study has been selected for viewing. 2. discrepancies in colors and size of the affected area were observed when the customer uses the "time sensitive" and "time insensitive" methods a sub option of the brain perfusion option. user issue: in the multi-modality tumor tracking application discrepancies in lesion measurements were observed when edits were made to the contours and the editing tool was not closed before moving onto another lesion or stage.

Device

INTELLISPACE PORTAL HX
  • Modelo / Serial
    Model Catalog: 4598 001 30491 (Lot serial: ); Model Catalog: 4598 001 31131 (Lot serial: N/A FOR ALL)
  • Descripción del producto
    INTELLISPACE PORTAL HX
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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