Events

Retiro De Equipo (Recall) de VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT

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
    86178
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-11-17
  • 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
    Philips volcano is initiating a voluntary correction to address a configuration issue that affects some s5i and core mobile systems with software version v3.5 ("impacted systems"). on certain impacted systems an unexpected microsoft windows security dialog may appear during use and the user's response to the dialog may adversely affect the subsequent operation of the device. the microsoft windows security settings on a small number of impacted systems were incorrectly configured during the manufacturing process. this misconfiguration can lead to a windows security alert dialog being displayed when the system is switched from ivus to the ffr/ifr mode. if the user responds to the dialog by selecting "allow access" the device's network firewall settings will be modified opening its network ports to potential unexpected communication from the hospital network to which the device is connected. unexpected communication from the hospital network could include normal network security operations e.G. port scanning. if these communications occur during an active ffr/ifr procedure data recording could be affected leading to: -incorrect ffr/ifr measurements -case delay during troubleshooting and/or port scanning -abandonment of use of the system based on our investigation there is only a remote probability that any of these impacts may occur. (see s64 for french translation).

Device

VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT
  • Modelo / Serial
    Model Catalog: 400-0100.01 (Lot serial: ALL); Model Catalog: 807400-001 (Lot serial: ALL)
  • Descripción del producto
    VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT;S5I IMAGING SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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