Events

Rappel de MX 16-Slice (Full body CT 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 Philips Electronics Australia 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-00849-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-12
  • 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-00849-1
  • 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
    Philips healthcare received a report stating that a doctor received a finger pinch from the table top, which resulted in injury. the injury occurred when the doctor placed their hand at the end of the table top. the operator of the system did not notice that the doctor's finger was positioned at the pinch point when they started the movement of the table top.
  • Action
    Philips will be providing additional warning labels and instructions to users to prevent this issue from occurring. In the interim, Philips Healthcare is advising users to ensure CT scanner room access is controlled by procedures and policies that identify authorised personnel, and includes that patient or bystanders are to keep hands away from the table top when moving. Philips is advising operators to observe the status of patient or bystander when operating the control panel and CT-Box to control patient table.

Device

MX 16-Slice (Full body CT system)

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA