Events

Rappel de Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 with the following versions: (Computed tomography (CT) full-body diagnostic X-ray system)

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-2015-RN-00755-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-20
  • 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-2015-RN-00755-1
  • 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
    Some scans unexpectedly set the axial (z axis) scan length to a greater length than the user set in the plan.The issue occurs only when the following 3 conditions are met:· the plan employs dual-surview· the plan requests either a sagittal or a coronal reconstruction.· the gantry is tilteddue to this issue, there is a potential for undesired radiation to areas not intended to be scanned.
  • Action
    Philips is developing a new version of software that will eliminate the defect. Deployment of this new software will begin before the end of April, 2016. All customers will be updated by the end of October, 2016. In the interim, to eliminate the possibility of the defect from occurring, the user can eliminate any one of the three conditions (identified above) needed to trigger the behaviour. If the user chooses to eliminate the reconstruction from the plan, then that reconstruction can be created after the scan is complete. This action has been closed out on 15 June 2017.

Device

Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 with the following versions: (...
  • Modèle / numéro de série
    Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 with the following versions: (Computed tomography (CT) full-body diagnostic X-ray system)4.0.x.xxxx – Any version of 4.04.1.y.xxxx – Only version up to and including 4.1.4.ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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