Events

Rappel de Philips BrightView XCT

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
    19646
  • Date de mise en oeuvre de l'événement
    2016-01-15
  • 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
    Customer complaint indicated that after a software upgrade to version 1.2.3/ 2.5.3 or higher the following issue started to occur. upon completion of a patient study when the operator selected a pre-prorgammed motion (ppm) to remove the patient from the table. the table moved first instead of the detector (as it had done prior to the software upgrade). there is a potential for the patient to contact the collimators if the detctors are placed in close proximity to the patient at the end of an acquisition, followed by acquisition ofanother ppm due to te sequence of motions mentioned above.
  • Action
    Software to be upgraded

Device

Philips BrightView XCT

Manufacturer

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