Events

Rappel de Philips BrightView XCT Imaging 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 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
    15353
  • Date de mise en oeuvre de l'événement
    2013-09-16
  • 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
    Philips received a report from the field that the fpd failed to remain securely latched in the stowed position., a system warning message appeared warning the user that the fpd was unlatched. by design, the unlatching of the fpd caused the system to activate the e-stop. in an attempt by the operator to clear the warning message while in the 0 degree position, the fpd released from the stowed position.
  • Action
    Product to be modified

Device

Philips BrightView XCT Imaging System

Manufacturer

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