Events

Rappel de Luminos dRF (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-2014-RN-00456-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-17
  • 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-00456-1
  • 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
    Under rare environmental conditions (i.E., extremely dry air in combination with a highly isolated floor) electrostatic discharges (esd) >8 kv at the system control console may trigger an unintended movement of the system which may cause an emergency situation, danger to the patient (e.G., falling off the table, squeezing), to operating personnel or to the unit. to date, a sporadic occurrence of this system malfunction has been reported from two sites.
  • Action
    Customers are advised to press one of the red emergency STOP buttons immediately in case of an unintended movement. The system needs to be restarted afterwards to be fully functional again. Siemens is preparing a modification of the Luminos dRF system control console that will resolve this potential malfunction. The field modification will be available from May 2014.

Device

Luminos dRF (Fluoroscopic diagnostic x-ray systems)
  • Modèle / numéro de série
    Luminos dRF (Fluoroscopic diagnostic x-ray systems)Catalogue number: 10094200 ARTG Number: 102182
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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