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-2015-RN-00035-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-01-19
  • 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-00035-1
  • 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
    An internal bolt intended to hold the control panel in a fixed position can fail. if this bolt fails, the operator cannot lock the control panel into position, and the steering and rotation of the console will also be affected. the up/down positioning is not affected. portable exams are not possible and bedside exams are more difficult without these positioning capabilities. there is potential risk for not controlling the system during transport or during a patient examination. potential harms include bruises, cuts, scrapes, or broken bones. to date no patient injury has been reported.
  • Action
    Affected customers will be contacted by Siemens to schedule the necessary repairs on site. This action has been closed-out on 03/08/2016.

Device

ACUSON SC2000 ultrasound systems
  • Modèle / numéro de série
    ACUSON SC2000 ultrasound systemsSystem material number 10433816 (specific serial number range with component material number 10852376 installed)ARTG number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

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