Events

Rappel de AXIOM Artis, Artis zee and Artis Q/Q.zen system (fluoroscopic angiographic x-ray system)

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-2016-RN-01004-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-28
  • 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-2016-RN-01004-1
  • 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 identified that contaminants in the form of biomass can develop in the cooling system of artis systems, which can result in damage to the pump system. the presence of contaminants in the tube cooling circuit could impair the performance of the pump. the tube assembly can become overheated so that no radiation can be released. there is a risk that an ongoing procedure cannot be continued, however, the probability of this occurring is unlikely.
  • Action
    Siemens is advising users that a technician will be installing an additional external filter in the cooling water circuit to prevent the failure of the pump system. A further correction will be implemented to prevent the development of biomass in the cooling circuit as a permanent correction. Siemens is advising that there is no requirement to re-examine patients.

Device

AXIOM Artis, Artis zee and Artis Q/Q.zen system (fluoroscopic angiographic x-ray system)
  • Modèle / numéro de série
    AXIOM Artis, Artis zee and Artis Q/Q.zen system (fluoroscopic angiographic x-ray system)Catalogue/Lot Numbers: 5904433, 5904649, 5904466, 5904441, 5904656, 7728350, 7007755, 7412807, 7727717, 7728392, 7413078, 5917054, 7555373, 7555357, 7008605, 7555365, 10502501, 10848280, 10848353, 10502502, 10848281, 10848354, 10502505, 10848283, 10502504, 10848282, 10848355, 10502507, 10094135, 10094142, 10094137, 10094143, 10094141, 10094139, 10280959ARTG Numbers: 102173, 27395, 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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