Events

Rappel de Infant Warmer System (IWS)

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-2016-RN-01189-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-13
  • 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-2016-RN-01189-1
  • 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 related to loose screws in the “heater head” of certain infant warmer system (iws) devices. hot screws from the “heater head” of the iws could fall onto the bed if the “heater head” assembly has been improperly serviced. this could result in thermal injury to a patient. to date, two injuries have been reported as a result of this issue.
  • Action
    GE Healthcare is providing users with interim instructions to check the screws on the "Heater Head" are tight. This will form part of the annual Preventative Maintenance check to ensure the screws are tightened. This action has been closed-out on 23/05/2017.

Device

Infant Warmer System (IWS)
  • Modèle / numéro de série
    Infant Warmer System (IWS)Model Numbers: 3000 IWS, 3300 IWS, 3400 IWS and 4400 IWSARTG Number: 139290
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd