Events

Retiro De Equipo (Recall) de Volcano s5i, CORE, CORE Mobile Systems with software version V3.5

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Life Healthcare Pty 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
    RC-2017-RN-01473-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01473-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    Life Healthcare is arranging a service technician to visit customers to validate affected systems. In the interim, users may follow the workaround instructions provided in the customer letter to bypass changes to the firewall permissions that may impact the system.

Device

Volcano s5i, CORE, CORE Mobile Systems with software version V3.5
  • Modelo / Serial
    Volcano s5i, CORE, CORE Mobile Systems with software version V3.5 Part Numbers: 80740001, 400-0100.07, and 400-0100.02Manufactured between 23 March 2016 to 18 October 2017ARTG Number: 131371
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd