Events

Rappel de Brilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity Elite and Ingenuity CTSoftware release versions between 4.0.0 and 4.1.2 inclusive

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-00212-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-13
  • 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-00212-1
  • 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 is possible for the system to invert the sign (positive/negative) of the longitudinal position value displayed on an axial scan image. the following key events must take place for harm to occur:- the patient is placed in a “feet-first” orientation.- an interventional ct procedure is scheduled.- contrary to typical clinical practice, a multi-planar reconstruction (mpr) is used for planning the interventional procedure (this issue only occurs in images produced using mpr).- a check scan is not performed (normal clinical practice indicates the use of a check scan before beginning an interventional procedure).- - the needle tip placement is not confirmed as directed (this practice would prevent more than a minimal ingress of an intervention at an undesired location).
  • Action
    Philips is advising their customers to refrain from using Multi Planar Reconstruction (MPR) derived images for identifying the absolute position of the intervention for feet-first patient orientation. A software update will be implemented to correct the issue. This action has been closed-out on 4/08/2016.

Device

Brilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Co...
  • Modèle / numéro de série
    Brilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity Elite and Ingenuity CTSoftware release versions between 4.0.0 and 4.1.2 inclusiveARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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