Events

Rappel de Philips BrightView XCT and Philips BrightView X to XCT Upgrade Kit

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-2017-RN-00210-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-02-09
  • 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-2017-RN-00210-1
  • 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
    It has been identified that the intended use statement listed in the instructions for use (ifu) is stated incorrectly. a revision of the ifu with amendments (specifically regarding the functional capabilities of the system) will be released. the amended intended use in the ifu is as follows:brightview xct is a gamma camera for single photon emission computed tomography (spect) and integrates with an attenuation device consisting of flat panel x-ray imaging components. brightview xct produces non-attenuation corrected spect images and attenuation corrected spect images with x-ray transmission data that may also be used for scatter correction. the nuclear medical images and brightview xct images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localisation of the nuclear medicine data. the brightview xct imaging system should be used only by trained healthcare professionals.
  • Action
    Philips is advising users to be aware of the updated "Intended Use Statement" highlighted in the Customer Information Letter Users are further advised to continue using the system according to their training.

Device

Philips BrightView XCT and Philips BrightView X to XCT Upgrade Kit
  • Modèle / numéro de série
    Philips BrightView XCT and Philips BrightView X to XCT Upgrade KitModel Numbers: 882482 and 882454All software versionsARTG Number: 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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