Events

Rappel de ACUSON X700 Ultrasound System with software versions 1.0.00, 1.0.01, 1.0.02, 1.1.00 or 1.1.02

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-00420-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-08
  • 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-00420-1
  • 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
    When foursight 4d ultrasound imaging, 3-scape real-time 3d imaging, or anatomical m-mode are used during an obstetric or gynecology studies, the following data from the previous patient could replace the current patient's data in the report:- clinical lmp (last menstrual period)- clinical edc (estimated date of confinement)- clinical ma (menstrual age)- indicationif the replaced data is not noticed, there is a potential risk of performing additional diagnostic or non-indicated therapeutic procedures.
  • Action
    To avoid this scenario, the following steps are recommended by Siemens: - Always review the patient report at the end of each study and confirm the report contains only measurements and patient data relevant to the exam just performed. - Before exiting fourSight 4D ultrasound imaging or 3-Scape (3D) imaging access and review the patient report. This step refreshes the data in the report. A new version of software resolving the error will be implemented in the affected units.

Device

ACUSON X700 Ultrasound System with software versions 1.0.00, 1.0.01, 1.0.02, 1.1.00 or 1.1.02
  • Modèle / numéro de série
    ACUSON X700 Ultrasound System with software versions 1.0.00, 1.0.01, 1.0.02, 1.1.00 or 1.1.02Catalogue/Lot number – 1065844 ARTG number: 137563
  • Manufacturer
    Siemens Ltd

Manufacturer

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