Events

Rappel de Engstrom Ventilator & Aespire View, Aisys and Avance Anaesthesia MachinesManufactured from 23 April 2013 to 22 July 2013

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-2013-RN-00953-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-09-11
  • 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-00953-1
  • 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 involving unresponsive buttons on the display of the engstrom ventilator and the aespire view, aisys and avance anaesthesia machines. as a result of a manufacturing issue, the buttons on the left, right and bottom keypads may not always detect button presses. this may result in the inability to access certain menu functions which could possibly lead to delay in treatment.
  • Action
    The user may notice that a button press may not actuate the desired function. Usually by pressing the key again, the device will respond as expected. If a button has no response, the menu function may be accessible through the use of the control wheel. If none of the above steps can be performed, discontinue use and contact a GE Healthcare Service Representative. GE Healthcare will correct all affected systems.

Device

Engstrom Ventilator & Aespire View, Aisys and Avance Anaesthesia MachinesManufactured from 23 Apr...
  • Modèle / numéro de série
    Engstrom Ventilator & Aespire View, Aisys and Avance Anaesthesia MachinesManufactured from 23 April 2013 to 22 July 2013Multiple serial numbers affectedARTG Number: 93955
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd