Events

Rappel de NX workstation with NX 3.0.8950 image processing software

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par AGFA HealthCare Australia.

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
    RC-2017-RN-00131-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-27
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00131-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Due to a memory issue, users are shown a warning message about unexpected error and possible incorrect data integrity. a reboot of the workstation computer after having received the warning message prevents the issue from occurring. at this stage, there has been one instance whereby the warning instructions were not followed and resulted in the image of one patient being archived in another patient’s record.
  • Action
    In order to prevent this issue, Agfa HealthCare is advising users to conduct a daily reboot of their workstation by completely turning off the computer and then restarting it. Users are further advised to follow all warning instructions as indicated on their NX workstation and reboot the workstation’s computer if a warning message appears. A new version of the NX software (3.0.9000) will be released shortly and users will receive this upgrade to their installations accordingly.

Device

NX workstation with NX 3.0.8950 image processing software
  • Modèle / numéro de série
    NX workstation with NX 3.0.8950 image processing softwareARTG Numbers: 119463, 173861, 178856
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia