Events

Rappel de Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos RHD, Luminos RF Classic, Luminos Fusion, Luminos Select (Fluoroscopic diagnostic x-ray systems)

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-00111-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-02-08
  • 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-00111-1
  • 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
    There is potential for malfunction in cases where the table vertical tilt movement is obstructed by a solid object resulting in a collision. this can result in damage to the system mechanics that may not necessarily prevent the table from functioning immediately, but can lead to complete failure of the table mounting mechanics. in this case, the table may drop resulting in potentially hazardous situations for patients and/or staff.
  • Action
    Siemens is advising customers to avoid any collision of the table with objects in the table's operating area. Customers should contact their Siemens service representative for a precautionary inspection should such a collision occur or have occurred in the past.

Device

Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos RHD, Luminos RF Classic, Luminos Fusion, Lu...
  • Modèle / numéro de série
    Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos RHD, Luminos RF Classic, Luminos Fusion, Luminos Select (Fluoroscopic diagnostic x-ray systems)ARTG Numbers: 102181 & 144246
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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