Events

Rappel de Ingenuity CT/Core/Core128/Flex, Brilliance CT Big Bore /iCT/iCT SP Systems

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-2016-RN-00066-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-15
  • 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-2016-RN-00066-1
  • 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
    Philips identified an issue due to hydrogen embrittlement of fasteners during manufacture of ct systems. it was determined the issue was due to trapped hydrogen introduced into the fastener during electroplating operations performed by a philips supplier. hydrogen embrittled fasteners can crack and fail suddenly when under stress. assessment of these fasteners determined that sufficient mitigations were in place such that a single-point failure did not exist. even should two fasteners fail for the same component, the occurrence of harm was determined to be less than remote. there have been no complaints associated with this issue, and no reports of injury or death.
  • Action
    Philips will replace the affected service latch fasteners for the units in the field. Philips is advising customers that in the interim, the affected CT systems have been determined to be safe for continued use.

Device

Ingenuity CT/Core/Core128/Flex, Brilliance CT Big Bore /iCT/iCT SP Systems
  • Modèle / numéro de série
    Ingenuity CT/Core/Core128/Flex, Brilliance CT Big Bore /iCT/iCT SP SystemsAffected Models:728306 – Brilliance iCT728311 – Brilliance iCT SP 728326 – Ingenuity CT728321 – Ingenuity Core728323 – Ingenuity Core128728317 – Ingenuity Flex728244 – Brilliance CT BigBore (Radiology)728243 – Brilliance CT BigBore (Oncology)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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