Events

Rappel de SonoSite NanoMaxx Ultrasound System, version 60.80.101.025

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-2012-RN-01159-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-15
  • 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-2012-RN-01159-1
  • 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
    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.
  • Action
    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