Events

Rappel de Sorg Jump Alpha, Jump Beta and Vector WheelchairsWheelchairs with back tubes made of section tubes with groove Manufactured between 01/2008 - 09/2015

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Motum 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-2018-RN-00070-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-23
  • 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-2018-RN-00070-1
  • 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
    Motum has been made aware by the manufacturer, sorg, through continuous market observation, a potential weakness with a certain configuration of back tubes on sorg wheelchairs from the production date range of 01/2008 to 09/2015 which may result in breakage of the back tube under extreme loads. to date, there have been no injuries or harm reported as a result of this issue.
  • Action
    Motum will be in contact with affected users to arrange for replacement of the backrest tubes.

Device

Sorg Jump Alpha, Jump Beta and Vector WheelchairsWheelchairs with back tubes made of section tube...
  • Modèle / numéro de série
    Sorg Jump Alpha, Jump Beta and Vector WheelchairsWheelchairs with back tubes made of section tubes with grooveManufactured between 01/2008 - 09/2015ARTG Number: 226472(Motum - Wheelchair, attendant/occupant driven)
  • Manufacturer
    Motum Pty Ltd

Manufacturer

Motum Pty Ltd