Events

Rappel de Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers (infant radiant warmer)

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-01081-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-10-23
  • 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-01081-1
  • 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 wherein the oxygen and air wall inlet fittings and/or labels on the back panel, were reversed during assembly. as a result, this may potentially have reversed air/oxygen mixer concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa. the settings of the blender knob will no longer be accurate.
  • Action
    If the affected unit is in use with a patient, GE is asking customers to disconnect the wall supply gas and switch to tank supply. If the affected unit is not currently in use, GE is asking customers to take the unit out of service. A GE Field Engineer will be deployed to the affected site to complete the required repair.

Device

Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers (infan...

Manufacturer

GE Healthcare Australia Pty Ltd