Events

Rappel de Brilliance iCT (Model 728306), Brilliance iCT SP (Model 728311) and IQon Spectral CT (Model 728332) Scanner systems Manufactured beginning May 2009

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-01454-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-12-04
  • 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-01454-1
  • 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
    There is a possibility that screws holding an internal portion of the gantry (reaction ring) to the scanner’s main bearing may come loose. if this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry. there is no potential for harm to the patient or operator due to this issue.
  • Action
    Philips is advising users that they will be inspecting the affected systems, tightening and replacing the reaction ring screws as needed at no additional cost. (Reference: Field Correction FCO 72800690)

Device

Brilliance iCT (Model 728306), Brilliance iCT SP (Model 728311) and IQon Spectral CT (Model 72833...
  • Modèle / numéro de série
    Brilliance iCT (Model 728306), Brilliance iCT SP (Model 728311) and IQon Spectral CT (Model 728332) Scanner systemsManufactured beginning May 2009ARTG: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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