Events

Rappel de BrightView XCT and BrightView X- upgraded with the XCT Flat Panel Detector (Gamma camera)

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-00682-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-27
  • 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-00682-1
  • 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 a daily xct quality assurance phantom scan for image quality and hounsfield unit (hu) linearity an operator experienced resistance when engaging the locking handle of the fpd in the deployed position. with the locking handle in the locked position, the flat panel detector (fpd) locking mechanism was not locked, moved unexpectedly and contacted the imaging detector during system movement. philips’ investigation determined that the internal linkage shaft broke preventing the fpd from being locked into its correct deployed position.
  • Action
    Philips Healthcare Field Service Engineers will undertake a field corrective action to ensure no unexpected movement of the Flat Panel Detector. Philips is advising their customers to cease use of the XCT Flat Panel Detector until the implementation of the field corrective action. This action has been closed-out on 18/02/2016.

Device

BrightView XCT and BrightView X- upgraded with the XCT Flat Panel Detector (Gamma camera)
  • Modèle / numéro de série
    BrightView XCT and BrightView X- upgraded with the XCT Flat Panel Detector (Gamma camera)ARTG Number: 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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