Events

Rappel de Philips BrightView XCT SPECT/CT Combination with XCT Flat Panel Detector

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 Radiation Oncology Systems.

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
    16937
  • Date de mise en oeuvre de l'événement
    2014-07-07
  • 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
    The manufacturer has received a report that an operator experienced resistance when engaging the locking handle of the fpd in the deployed position. with the locking handle in the locked position, the fpd locking mechanism was not locked, moved unexpectedly and contacted the imaging detector during system movement. philips' investigation determined the internal linkage shaft broke preventing the fpd from being locked into its correct deployed position.
  • Action
    Product to be modified

Device

Philips BrightView XCT SPECT/CT Combination with XCT Flat Panel Detector

Manufacturer

Philips Radiation Oncology Systems
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA