Events

Rappel de CARESCAPE Monitor B650 Software Versions: 1.1.12.26 or earlier

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-2014-RN-00594-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-05-29
  • 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-2014-RN-00594-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue due to possible sound loss associated with the carescape monitor b650. when an external display is connected to the carescape monitor b650 using a usb extender cable with an active usb hub, the system may experience a sound loss including alarm sounds from the patient monitor. this may occur if the external display is powered off and on during normal operation of the monitor.
  • Action
    GE is advising their customers that this issue can be avoided by not switching the external display off and then switching it back on during normal monitor use and by not using a USB extender cable with active hub. If the sound loss occurs during normal operation of the monitor, users can enable the sounds back on by restarting the monitor. A software patch will be provided to correct this issue permanently.

Device

CARESCAPE Monitor B650 Software Versions: 1.1.12.26 or earlier

Manufacturer

GE Healthcare Australia Pty Ltd