Events

Retiro De Equipo (Recall) de SonoSitePowerPark Dock and Stand Module(s) used with SonoSite Ultrasound Systems 1) PowerPark Stand and DockModule(s) used in conjunction with the X-Porte Ultrasound System 2) PowerPark Stand Module(s)

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-2015-RN-00305-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-22
  • 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-2015-RN-00305-1
  • 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
    Powerpark consists of two components: thestand module (attaches to the underside of the sonosite stand) and the dock module (plugs into a power outlet and sits on the floor).1) when used in conjunction with x-porte ultrasound system stand, damage to the powerpark modules can occur by a docking approach from extreme angles or from excessive movement of the stand when docked. if the powerpark experiences too much connector damage (i.E. blackened pins) it could berendered inoperable and it will stop charging the system.This issue affects both the stand module and dock module . 2) during the manufacturing process of the stand module, an incorrect component was used. this component leaves the affected stand module out of specification. stand modules manufactured with this incorrect component will need to be returned to sonosite for serviced at the expense of sonosite.
  • Acción
    To resolve these issues, it is necessary to perform a replacement of the affected PowerPark as follows: 1) SonoSite requires that customers to return the Stand Module with the X-Porte stand. Additionally, the PRIMARY Dock Module that has been utilised with the X-Porte stand will need to be returned and replaced. 2) Stand Modules manufactured with the incorrect component will need to be returned to SonoSite for serviced at the expense of SonoSite. Stand Modules will be inspected, serviced to be within specification, and returned. This action has been closed-out on 29/08/2016.

Device

SonoSitePowerPark Dock and Stand Module(s) used with SonoSite Ultrasound Systems 1) PowerPark Sta...
  • Modelo / Serial
    SonoSitePowerPark Dock and Stand Module(s) used with SonoSite Ultrasound Systems 1) PowerPark Stand and DockModule(s) used in conjunction with the X-Porte Ultrasound System 2) PowerPark Stand Module(s) Part Numbers: P12822-25, P12822-26, P13740-01, P13871-10, P13871-11 andP13736-01Manufactured from July 2012 through December 2014ARTG Number: TBA
  • Manufacturer
    Fujifilm Sonosite Australasia Pty Ltd

Manufacturer

Fujifilm Sonosite Australasia Pty Ltd