Events

Retiro De Equipo (Recall) de Volcano S5, S5i, CORE, CORE Mobile Systems with software versions v3.2x, v3.3, v3.4.1 (used to diagnose anatomical defects of the heart or problems associated with myocardial infarction)

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-2016-RN-00602-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-05-10
  • 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-2016-RN-00602-1
  • 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 manufacturer, volcano corporation has become aware of a system incompatibility issue between the affected systems and hospital network scans. in specific circumstances, a system will encounter unexpected data from the hospital network and the system will need to be manually rebooted. this condition can occur any time, including in the middle of a patient procedure.The system incompatibility issue occurs when hospital staff scan their networks for potential security vulnerabilities and the user is required to manually reboot the system. if this issue occurs during an active procedure, a reboot would result in a delay in the procedure and/or abandonment of the use of ivus and ffr/ifr functionality in the procedure. there have been no reports of injuries associated with this issue.
  • Acción
    LifeHealthcare is providing users with work around instructions to follow as an interim measure. A correction is being developed as a permanent correction. This action has been closed-out on 24/05/2017.

Device

Volcano S5, S5i, CORE, CORE Mobile Systems with software versions v3.2x, v3.3, v3.4.1 (used to di...
  • Modelo / Serial
    Volcano S5, S5i, CORE, CORE Mobile Systems with software versions v3.2x, v3.3, v3.4.1 (used to diagnose anatomical defects of the heart or problems associated with myocardial infarction)ARTG Number: 131371
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd