Events

Rappel de Artis zee, Artis Q and Artis Q.zen systems with software version VD11B

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 Healthcare Pty 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-2016-RN-01637-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-12-20
  • 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-2016-RN-01637-1
  • 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
    During regular field observations siemens have identified a software issue with two possible, mutually independent causes of a system defect, these are as follows:1. in artis systems with a100plus or a100g generators, an attempt to resume operation following detection of a fault (such as a short circuit in the x-ray tube) can result in the failure of a module in the high-voltage generator; and2. for biplane systems delivered with software version vd11b since april of this year, software problems in conjunction with the graphics card may in rare cases result in the loss of image display in the examination room.Siemens advises they do not consider it necessary to re-examine any patients in this case and that this is a possible hardware defect that has no influence on the treatment of patients.A system software update will implement additional protective mechanisms for the generator and correct the software problem.
  • Action
    Siemens will be contacting affected users to arrange a date to perform a system software update, which will implement additional protective mechanisms for the generator and correct the software problem.

Device

Artis zee, Artis Q and Artis Q.zen systems with software version VD11B
  • Modèle / numéro de série
    Artis zee, Artis Q and Artis Q.zen systems with software version VD11BCatalogue/Lot Numbers: 10848281, 10848355, 10848282, 10848280, 10094139, 10094137, 10848353ARTG Number: 273952
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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