Events

Rappel de Mammomat Inspiration System with software version VB30 and Biopsy functionality

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 Healthcare 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-2017-RN-00071-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-17
  • 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-2017-RN-00071-1
  • 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
    Siemens has become aware of potential errors that may occur while performing a biopsy. the system may freeze and biopsy functionality may become unavailable in the following situations:- drop of the compression force, e.G. this may occur due to a patient's sudden movement during the active targeting phase- use of the inversion tool while the scout image is active during the targeting phase.As a result of system freeze, the biopsy may have to be repeated.
  • Action
    Siemens will release a software update to resolve the issue. Siemens service engineer will contact affected customers to schedule the software update. In the interim, Siemens is advising users to follow these instructions: 1) Do not close the error message window when it is displayed. Instead, cancel the active target before closing the window. Users can start all over after the completion of these steps. 2) Users are advised not to use the inversion tool while the scout image is active. In the event of a system freeze, the acquisition workplace must be rebooted.

Device

Mammomat Inspiration System with software version VB30 and Biopsy functionality
  • Modèle / numéro de série
    Mammomat Inspiration System with software version VB30 and Biopsy functionalityCatalogue Number: 10140000 (with software version VB30 and with a Biopsy option)ARTG Number: 274541
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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