Events

Rappel de ACUSON SC2000 Ultrasound Systems

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens 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-2014-RN-00005-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-01-03
  • 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-2014-RN-00005-1
  • 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
    The user interface module on the ultrasound system consists of the console (monitor, control panel and keyboard) and the swivel mechanism., the swivel mechanism is used for adjusting the height and rotation of the console and is attached to the column on the ultrasound system. if the connection of the user interface module to the column on the ultrasound system is lose, the entire module may fall off the ultrasound system. there is a potential risk of striking and harming anyone in the environment of the ultrasound system.
  • Action
    End users are advised to inspect their units for any looseness in the attachment of the interface module to the column on the ultrasound system. If looseness is observed, discontinue use immediately and contact a Siemens service representative. A service engineer will perform the necessary repairs.

Device

ACUSON SC2000 Ultrasound Systems
  • Modèle / numéro de série
    ACUSON SC2000 Ultrasound SystemsCatalogue Number: 10433816Serial Numbers lower than 401100ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA