Events

Rappel de Philips Ingenuity CT System

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Philips Medical Systems (USA).

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
    19640
  • Date de mise en oeuvre de l'événement
    2016-01-20
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Cause
    During manufacturing philips identified an issue involving hydrogen embrittlement of fasteners used in the manufacture of ct systems. it was determined this 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
    Manufacturer to issue advice regarding use

Device

Philips Ingenuity CT System

Manufacturer

Philips Medical Systems (USA)
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA