Events

Rappel de Artis Q and Artis Q zen systems (Fluoroscopic 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-00782-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-11
  • 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-00782-1
  • 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 i identified the following issues with the artis q and artis q zen systems:1. in certain circumstances the release of radiation is blocked in connection with an error with the large display, for example, where an image cannot be displayed on the large display. in rare cases the system misinterprets the status of the large display and blocks the release of radiation.2. in the case of installations configured with a hospital emergency power supply for the entire system, radiation release may be blocked due to a software error, because a non-existent emergency power situation is detected by mistake.3. the coupling of failures caused by an electronic control element might lead to a radiation abort.
  • Action
    Siemens is providing a software patch to correct this issue. The software limits the blockage of radiation release to three seconds and the screen in the control room displays the message "No Xray, try again". After the next attempt, radiation can then be released without restriction. The software modification also prevents misinterpretation of the emergency power supply issue. An additional hardware signal supression component will be fitted to mitigate electronic control element failure. This action has been closed-out on 01/03/2016.

Device

Artis Q and Artis Q zen systems (Fluoroscopic X-ray systems)
  • Modèle / numéro de série
    Artis Q and Artis Q zen systems (Fluoroscopic X-ray systems)Multiple material numbers with software VD10D and Large DisplayARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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