Events

Rappel de Brilliance CT Systems and Gemini & Precedence Systems utilising Brilliance CT Brilliance CT (6, 10, 16, 16P, 40, 64 and Big Bore), Brilliance iCT, Brilliance iCT SP

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-2013-RN-00555-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-05-31
  • 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-2013-RN-00555-1
  • 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
    The stated tolerance in the instructions for use manual for the recorded scanner output (ctdivol) that is used to approximate patient dose does not accurately represent all systems. on some systems, the measured ctdivol value may fall outside of these stated tolerances. in a worst case scenario, there is the potential for the delivered dose to exceed the reported dose by an amount almost equivalent of a rescan.
  • Action
    Philips is providing their customers with additional information that clarifies published specifications and correlation of CTDIvol value measurement.

Device

Brilliance CT Systems and Gemini & Precedence Systems utilising Brilliance CT Brilliance CT (6, 1...
  • Modèle / numéro de série
    Brilliance CT Systems and Gemini & Precedence Systems utilising Brilliance CT Brilliance CT (6, 10, 16, 16P, 40, 64 and Big Bore), Brilliance iCT, Brilliance iCT SPMultiple product codes affectedARTG Number: 98868Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore Multiple product codes affectedARTG Number: 118077Precedence SPECT/CTMultiple product codes affectedARTG Number: 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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