Events

Retiro De Equipo (Recall) de BRILLIANCE ICT SP SYSTEM - MAIN

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
    67756
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2018-02-14
  • 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
    Upon closing the emergency stop (e-stop) the system performs an internal check. as a result of the motion controller in the couch there is a delay in the response to the internal check. this delay may cause the couch carbon top to enter a free float state which may allow it to move during patient load or unload activities. this free float motion results in the estop being opened due to the unexpected couch motion. this issue occurs frequently after closing e-stop. the motion controller in the couch detects a power problem and disables the horizontal motor which allows the couch top to free-float*. *the term free float refers to the couch top being in a state that is not locked in position by the brake or being moved in a controlled fashion (manual or automatic motion).

Device

BRILLIANCE ICT SP SYSTEM - MAIN
  • Modelo / Serial
    Model Catalog: 728311 (Lot serial: N/A); Model Catalog: 4535 670 88051 (Lot serial: N/A); Model Catalog: 728244 (Lot serial: N/A); Model Catalog: 728306 (Lot serial: N/A); Model Catalog: 728326 (Lot serial: N/A); Model Catalog: 728323 (Lot serial: N/A)
  • Descripción del producto
    BRILLIANCE ICT SYSTEM- SYSTEM;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