Events

Rappel de Carescape Monitor B850, all software versions (mutliparameter patient monitor)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare 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-2012-RN-00807-3
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-08-08
  • 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-2012-RN-00807-3
  • 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
    Ge healthcare has recently become aware of potential issues with the carescape monitor b850 as outlined below:1. carescape monitor b850 udom failure. it is possible that the carescape monitor b850 may enter into a constant book loop causing monitor to reboot continuously. 2. carescape monitor b850 unstable usb communication. when the usb cable is connected to the cpu or display is insecurely connected or faulty, the monitor may reboot. reboot may also happen if the monitor display is continuously set on and off several times. 3. carescape monitor b850 remote printing issue with currently printing prn 50 recorder. if the recorder prn 50 is busy when the carescape monitor b850 sends a printing request, the printing may not be saved and therefore not printed.4. carescape monitor b850 reboots due to an x server freeze.
  • Action
    GE Healthcare will be implementing a software and hardware correction.

Device

Carescape Monitor B850, all software versions (mutliparameter patient monitor)
  • Modèle / numéro de série
    Carescape Monitor B850, all software versions (mutliparameter patient monitor)ARTG Number: 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd