Events

Rappel de Artis Q and Artis Q.zen Ceiling Systems (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 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-01307-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-12-12
  • 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-01307-1
  • 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
    During regular product monitoring, wear on system cabling was identified. in particular, wear may occur at the cable outlet of the inner c-arm. this problem is not systematic, but occurs sporadically on individual systems throughout the lifetime of the system. suboptimal routing of the cable may result in increasing wear. without intervention to manage this wear, damage to cabling may result in limited functionality and, in the worst case, system failure where a procedure may need to be terminated.
  • Action
    The existing cable routing at the C-arm will be modified to prevent cable damage. The following hardware modification will be implemented in the field : 1. A modified cable outlet to provide additional space for the cabling. 2. A modified plastic cover at the cable outlet providing optimal cable guidance in the area most at risk of wear All systems will be checked to determine if there is existing damage to cabling. Where damage is observed, the entire cable harness will be replaced. This action has been closed-out on 14/07/2016.

Device

Artis Q and Artis Q.zen Ceiling Systems (Fluoroscopic angiographic x-ray system))
  • Modèle / numéro de série
    Artis Q and Artis Q.zen Ceiling Systems (Fluoroscopic angiographic x-ray system)) Serial Numbers: 109000 to 109091 (Artis Q), and 111000 to 111005 (Artis Q.zen)ARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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