Events

Rappel de Siemens Ysio Max, Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max with software version VE10E(fluoroscopic and standard 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-2015-RN-00361-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-23
  • 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-00361-1
  • 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
    Images might be lost and corresponding acquisitions have to be repeated under the following circumstances:· during an image recovery process on systems with portable detectors (max wi-d, max mini) the connection of the portable detector is sporadically not re-established.· if either the “undo” button on the rad subtask card or the “previous series” button on the image subtask card are pressed during image readout.· sporadically, during an automatic or a manual ris update. this may cause the deletion of the currently used study and all acquired images within this study.
  • Action
    Siemens is providing temporary instructions for users to follow to prevent the issues from occurring. A software update will be available in Q2 2015 which will permanently resolve the issue. This action has been closed-out on12/08/2016.

Device

Siemens Ysio Max, Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max with software version ...
  • Modèle / numéro de série
    Siemens Ysio Max, Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max with software version VE10E(fluoroscopic and standard diagnostic x-ray systems )Catalogue Numbers: 10762470, 10762471ARTG Numbers: 102184, 102182, 213886
  • Manufacturer
    Siemens Ltd

Manufacturer

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