Events

Rappel de Luminos dRF and Uroskop Omnia systems with Software Version VD10

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-2013-RN-01083-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-25
  • 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-2013-RN-01083-1
  • 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 the following potential malfunctions:1. during a rad (radiography) examination with automatic exposure control, a highly unlikely malfunction can result in radiation continuing longer than required. this malfunction happens when the generator stops the tube power too late and therefore too much dose is applied during an acquisition. this may also result in an overexposed image that is not of diagnostic quality, so that the examination needs to be repeated. (note: this issue also affects software versions vc10 and vb10. devices running this software are being corrected under recall rc-2013-rn-01037-1.)2. when selecting a tomo ogp, in some cases the luminos drf system shows a message "wait for flc" and this state does not change on its own.3. radiation is not activated and therefore an exposure is performed without radiation.
  • Action
    It is not possible for the user to prevent this malfunction. The exposure time with the use of automatic exposure control is limited to 500ms, which is the maximum time that unwanted radiation will continue. The exposure can be interrupted by the user at anytime by releasing the exposure button. Siemens has implemented a field modification that will resolve the issues. The Australian roll out of this field modification is planned for completion in Q4 2013/Q1 2014.

Device

Luminos dRF and Uroskop Omnia systems with Software Version VD10
  • Modèle / numéro de série
    Luminos dRF and Uroskop Omnia systems with Software Version VD10Catalogue Numbers:10094200, 10094910Siemens Reference Numbers: XP031/13/SARTG Number: 102184
  • Manufacturer
    Siemens Ltd

Manufacturer

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