Events

Retiro De Equipo (Recall) de SonoSite NanoMaxx Ultrasound System, version 60.80.101.025

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Fujifilm Sonosite Australasia 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-2012-RN-01159-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-15
  • 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-2012-RN-01159-1
  • 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
    During design verification testing, it was found that when using its nanomaxx ultrasound system configured with system software arm version 60.80.101.025 (referred to as nano 1.0.5) when the usb printer is selected from the pull down menu and the print command is selected, the status bar will freeze as expected during spooling. however, once the spooling is complete the status car does not unfreeze and information is not updated.
  • Acción
    Customers to contact SonoSite Technical support to arrange a software upgrade.

Device

SonoSite NanoMaxx Ultrasound System, version 60.80.101.025

Manufacturer

Fujifilm Sonosite Australasia Pty Ltd