Events

Rappel de Rotating IV Pole, used with Giraffe OmniBed Carestation, Giraffe Incubator Carestation Giraffe OmniBed, Giraffe Warmer, Panda Warmer, Giraffe Incubator, Care Plus Incubator, IWS, and Giraffe Shuttle.

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-2017-RN-01512-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-18
  • 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-2017-RN-01512-1
  • 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 the potential for the rotating iv pole to fall. a fall could result in an injury to a bystander holding the patient or to the operator.There have been no reported injuries as a result of this issue.
  • Action
    GE Healthcare is advising hospitals to discontinue use of the affected Rotating IV poles and remove from service. Place affected Rotating IV poles in a quarantine marked area. A GE Service Representative will contact customers to arrange for the removal & replacement of a new IV pole.

Device

Rotating IV Pole, used with Giraffe OmniBed Carestation, Giraffe Incubator Carestation Giraffe Om...
  • Modèle / numéro de série
    Rotating IV Pole, used with Giraffe OmniBed Carestation, Giraffe Incubator Carestation Giraffe OmniBed, Giraffe Warmer, Panda Warmer, Giraffe Incubator, Care Plus Incubator, IWS, and Giraffe Shuttle.Part Number: 6600-0851-800Multiple Affected Lot NumbersARTG Number: 168674, 139289
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd