Events

Rappel de BrightView XCT SPECT/CT 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 Philips Electronics Australia 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-01226-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-20
  • 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-2014-RN-01226-1
  • 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
    Philips has identified two issues with the brightview xct spect/ct systems: 1) whilst performing a clinical spect/ ct study on a brightview xct spect/ct systems, the ct portion of the scan may be interrupted and not complete successfully. this problem is not detectable by the user prior to the interruption of the ct acquisition. interruption of the ct acquisition portion of the scan may necessitate a re-scan of the interrupted segment, resulting in overall radiation to the patient being higher than planned. the additional radiation would be less than the amount delivered from a single successful scan of that body segment.2) investigation of generator faults from the field have identified that the ground connection on the x-ray generator cabinet may have been wired incorrectly during installation.
  • Action
    Philips is advising users of the issue and providing work around instructions should the problem occur. Philips is also updating the XCT generator configuration to increase tube life and implementing a software update.

Device

BrightView XCT SPECT/CT systems

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA