Events

Rappel de Philips Ingenuity CT, Ingenuity Core and Ingenuity Core 128

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
    17514
  • Date de mise en oeuvre de l'événement
    2014-10-10
  • 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
    This field safety notice to inform customers that software was upgraded from version 3.X to version 4.0.0 / 4.0.1, the protocol conversion can result in incorrect scan parameters, which in turn can result in delayed images, when using the cct option. report that first image was marked as "last shot" rather than the actual "last shot" acquired. after the clinician pressed the pedal for first exposure, images were displayed as the "last shot". subsequent pedal presses did not result in immediate image reconstruction and the first image remained on the screen labeled as the "last shot". eventually all images appeared., the problem is caused by incorrect slice increment settings in the user set for cct protocol resulting from the protocol to exam card conversion during the software upgrade from v3.X to v4.0.0 / v4.0.1.
  • Action
    Manufacturer to issue advice regarding use

Device

Philips Ingenuity CT, Ingenuity Core and Ingenuity Core 128

Manufacturer

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