Events

Rappel de Cios Alpha mobile C-arm 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-2015-RN-00818-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-28
  • 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-2015-RN-00818-1
  • 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 have received reports that under certain circumstances, when starting the system up or reconnecting the c-arm cable to the main unit, the error 5000/243 “no x-ray - fd re-initialises” may occur. the error refers to a potential hardware malfunction of the cios alpha c-arm x-ray system that may occur when starting the system up or reconnecting the c-arm cable to the main unit. when this occurs, the system will become inoperable until the affected part is replaced.
  • Action
    Siemens is planning to release a modification for the Cios Alpha mobile C-arm x-ray system that will resolve the above-mentioned potential malfunction. As soon as the modification is available, a Siemens service engineer will contact customers to schedule implementation of the modification for your system. Siemens is providing the following instructions to minimise the risk of this issue: · Ensure that the system is ready after the startup · Ensure that the error 5000/243 is not displayed, neither as message box nor in the FLC status bar (lower left side of the left monitor) · In general, avoid disconnecting and reconnecting the C-arm cable during or shortly before starting a procedure. This action has been closed-out on 31/08/2016.

Device

Cios Alpha mobile C-arm x-ray system
  • Modèle / numéro de série
    Cios Alpha mobile C-arm x-ray systemCatalogue/Lot number – 10308191ARTG Number: 102180
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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