Events

Retiro De Equipo (Recall) de BRILLIANCE ICT SYSTEM - EXTENDED BRILLIANCE WORKSPACE

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
    89585
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-10-03
  • 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 become aware of the following issues:1)when translating the calcium scoring(cs) results into chinese the percentile is not reported accurately.2)in the calcium scoring (cs) protocol the protocol is switched to mass score but the protocol name remains agatston. 3)spline measurement values do not update when adding control point (cp) and when changing the length of the line.4)in the ct viewer (ctv)pet studies being loaded from remote with slope different than 1 appear incorrectly in 2d scene and are not displayed with the correct suv values. 5)loading pet images in the ct viewer (ctv)quick review from remote with slope different than 1 the images with the different slope appear incorrectly with wrong suv values in perception and in qr.

Device

BRILLIANCE ICT SYSTEM - EXTENDED BRILLIANCE WORKSPACE
  • Modelo / Serial
    Model Catalog: 4550 110 02031 (Lot serial: 15000); Model Catalog: 4550 110 02031 (Lot serial: 12327); Model Catalog: 4550 110 02031 (Lot serial: 12159); Model Catalog: 4550 110 02031 (Lot serial: 14859)
  • Descripción del producto
    BRILLIANCE ICT SYSTEM-EXTENDED BRILLIANCE WORKSPACE
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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