Events

Rappel de Ceiling system for Artis Zee System (Fluoroscopic angiographic digital 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-2013-RN-01163-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-20
  • 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-2013-RN-01163-1
  • 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
    Cables in the cable harness of the ceiling carriage may have received wear and tear or damage resulting in loss of system movement or loss of complete functionality. siemens technical specialists have advised that this issue could result in a limited or total loss of functionality with regards to the system movement. the cable damage caused by this issue would only affect system movement, not the imaging. however, as this type of system may be used during procedures for the placement of catheters, pacemakers, transcatheter aortic valve implantations etc. the loss of system movement may limit the available imaging during this type of procedure.
  • Action
    Siemens is inspecting all potentially affected cables and installing an additional cable guide system to prevent wear if necessary.

Device

Ceiling system for Artis Zee System (Fluoroscopic angiographic digital x-ray system)
  • Modèle / numéro de série
    Ceiling system for Artis Zee System (Fluoroscopic angiographic digital x-ray system)Catalogue Number: 10094137Serial Numbers: 146367, 146674, 146718, 146880, 146910, 146926, 146967, 147054, 147092, 147095, 147101, 147102, 147518All systems equipped with a ceiling stand with serial numbers from 10701 to 11557ARTG Number: 120177
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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