Events

Rappel de Artis Zeego Systems (Fluoroscopic diagnostic x-ray system for angiographic procedures) with SW revision VC14, VC20 & VC21 in conjunction with a specific technical configuration

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-2012-RN-01165-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-30
  • 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-2012-RN-01165-1
  • 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
    In the course of siemens' product monitoring activities, a potential risk for patient or operators was determined during the operation of an artis zeego system with sw revision vc14, vc20 & vc21 in conjunction with a specific technical configuration which cannot be completely excluded. in case of an unlikely failure of brake, the c-arm may descent.This recall action was undertaken by siemens ltd before it was agreed with the tga.
  • Action
    All the affected systems were checked by Siemens technical engineer for the potential for the failure mode to occur.

Device

Artis Zeego Systems (Fluoroscopic diagnostic x-ray system for angiographic procedures) with SW re...
  • Modèle / numéro de série
    Artis Zeego Systems (Fluoroscopic diagnostic x-ray system for angiographic procedures) with SW revision VC14, VC20 & VC21 in conjunction with a specific technical configuration ARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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