Events

Rappel de Mini C-arm, models InSight and InSight 2 (Fluoroscopic x-ray system)

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

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-2013-RN-00401-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-05-03
  • 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-2013-RN-00401-1
  • 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
    Hologic has identified the following compliance issues:1. the audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate. 2. the total cumulative irradiation time display is not accurate. both issues are caused by computational error which truncates the fractions of seconds after each image and therefore the time to alarm and the time displayed are shorter by the sum of these fractions.
  • Action
    Hologic is providing their customers with a revised version of the software. End users are requested to update their systems in accordance with the instructions provided with the update.

Device

Mini C-arm, models InSight and InSight 2 (Fluoroscopic x-ray system)
  • Modèle / numéro de série
    Mini C-arm, models InSight and InSight 2 (Fluoroscopic x-ray system)ARTG 158774
  • Manufacturer
    Hologic Australia Pty Ltd

Manufacturer

Hologic Australia Pty Ltd