Events

Rappel de GE Optima XR220amx & XR220amx with Digital Upgrade X-Ray Systems

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
    15868
  • Date de mise en oeuvre de l'événement
    2013-12-13
  • 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
    Intermittently when a large number of patient exams are retrieved from the his/ris system, the exams when displayed on the mobile x-ray system are not properly displayed. if the user continues to attempt to select one of the exams when this issue has occurred, the system will update the screen and in doing so, potentially select a different exam/patient. if the user does not notice this change and continues to perform the exam, the images will be placed in an incorrect patient file.
  • Action
    Software to be upgraded

Device

GE Optima XR220amx & XR220amx with Digital Upgrade X-Ray Systems
  • Modèle / numéro de série
    Model: 5555000-5, 5555000-6 and 5421698, Affected: , Software version: All versions
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC