Events

Rappel de GE PET Discovery 600 and Discovery 690 Nuclear Medicine 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 GE Medical Systems LLC.

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
    16008
  • Date de mise en oeuvre de l'événement
    2014-01-09
  • 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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Cause
    A software issue exists when using list mode replay, such that subsequent reconstructions with that data could contribute to an image with scatter over-estimation and overcorrection. reconstructed images with this issue will have many fewer counts than the acquired scan data and a high scatter fraction., this issue may affect studies that use list mode replay and are reconstructed after subsequent acquisitions., this issue may lead to image misinterpretation and/or inaccurate treatment decisions.
  • Action
    Software to be upgraded

Device

GE PET Discovery 600 and Discovery 690 Nuclear Medicine System
  • Modèle / numéro de série
    Model: 600 & 690, Affected: , Software version: Software versions pet_mict_plus.44 and pet_velocity.53
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC