Events

Rappel de Ysio Max, Luminos dRF Max and Luminos Agile Max (with software version VE10 including SmarthOrtho license)

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-01318-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-12-15
  • 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-01318-1
  • 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 has identified a potential malfunction which can occur when composed images are flipped on the integrated imaging system flourospot compact. when composed images are flipped (vertically or horizontally) the image information might become corrupted as a result of a software malfunction. the affected images and associated annotations such as labels (e.G. r/l) may show incorrectly.The corrupt image information might lead to an incorrect diagnosis.
  • Action
    Siemens is providing a new software version that will permanently resolve the described malfunction. In the interim end users are advised to follow work around instructions to ensure the safe use of the systems Ysio Max, Luminos dRF Max and Luminos Agile Max systems. This action has been closed-out on 08/08/2016.

Device

Ysio Max, Luminos dRF Max and Luminos Agile Max (with software version VE10 including SmarthOrtho...
  • Modèle / numéro de série
    Ysio Max, Luminos dRF Max and Luminos Agile Max (with software version VE10 including SmarthOrtho license) ARTG Number: 102182, 102184
  • Manufacturer
    Siemens Ltd

Manufacturer

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