Events

Rappel de T2100 Treadmill

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-2015-RN-00259-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-19
  • 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-2015-RN-00259-1
  • 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
    A performance issue with the t2100 treadmills can cause uncontrolled walking belt motion during a stress exercise test. this motion can be seen as an unexpected slowing, followed by sudden belt acceleration in either the forward or backward direction. when this occurs, engaging the emergency stop button (estop) will not immediately stop the belt. rather, it will coast to a stop within 35 seconds when slowing from maximum speed. the sudden change in belt speed and/or direction can result in a fall and injury to the patient.
  • Action
    GE Healthcare is providing work around instructions to minimise the risk of an unexpected change in speed or direction. GE will correct all affected units onsite. This action has been closed-out on 12/08/2016.

Device

T2100 Treadmill

Manufacturer

GE Healthcare Australia Pty Ltd