Events

Rappel de Ysio Systems (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-00558-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-05-16
  • 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-00558-1
  • 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
    If excessive liquid is used for cleaning, the liquid may infiltrate the generator console and cause a short circuit which may lead to an unintended release of radiation. to date, only one customer has reported this occurrence.
  • Action
    Siemens has prepared a modification to resolve the potential issue by sealing the generator consoles of the Ysio Systems against infiltration of liquid. This modification will be installed as field correction likely to occur during 2nd to 4th quarter 2014. Until the modification is implemented, users are advised to strictly follow the user manual to avoid liquid infiltration into the generator console. This action has been closed-out on 18/08/2016.

Device

Ysio Systems (X-ray system)
  • Modèle / numéro de série
    Ysio Systems (X-ray system)Catalogue Numbers: 10281013 & 10281163ARTG Number: 102184
  • Manufacturer
    Siemens Ltd

Manufacturer

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