Events

Rappel 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)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Fujifilm Sonosite Australasia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00305-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-22
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00305-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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