Events

Rappel de Stereo Biopsy Device used with Mammomat Inspiration Mammography SystemMaterial number: 10140000 (Mammomat Inspiration)

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-01040-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-25
  • 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-01040-1
  • 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 stereo biopsy devices for mammomat inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. the pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. the needle positioning device may move even with the safety switch being set sideward. if this occurs with the needle being already inserted, it could lead to an unintentional patient injury.
  • Action
    Customers are advised that in case the needle holder moves unintentionally to press the emergency stop. Siemens is recommending inspection of the safety switch before every biopsy until the problem is solved. Siemens is preparing a modification of the safety switch that will resolve this potential malfunction. The field modification will be available beginning of October. This action has been closed-out on 07/06/2016.

Device

Stereo Biopsy Device used with Mammomat Inspiration Mammography SystemMaterial number: 10140000 (...
  • Modèle / numéro de série
    Stereo Biopsy Device used with Mammomat Inspiration Mammography SystemMaterial number: 10140000 (Mammomat Inspiration) Serial numbers: 1541, 2082ARTG number: 144223
  • Manufacturer
    Siemens Ltd

Manufacturer

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