Events

Rappel de 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 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
    21124
  • Date de mise en oeuvre de l'événement
    2017-02-21
  • 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 become aware of a potential problem with brightview xct, with software issues in 2.5.5 and earlier., issue 1 - motion controller emit the warning message, occasionally, the system may stop and you may receive a "xct scan did not complete successfully"., issue 2 - door interlock switch with x ray perform, system was unable to perform an x-ray scan, after the system displays a "xct door interlock error., issue 3 - detector contacts head holder when performing patient unload, when performing a preprogrammed motion (ppm) to unload the patient, the detector will contact the head holder under the following circumstances:, - head holder installed, - rel-180 detector orientation, - gantry rotate angle between 45° and 55°, issue 4 - jetstream freezes during gated planar scan, when acquiring a gated planar scan (muga - multi gated acquisition) on a patient with an irregular heartbeat, you may encounter a situation where the acquisition station locks at 100% complete.
  • Action
    Software to be upgraded

Device

Brightview XCT

Manufacturer

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