Events

Rappel de Oxford Advance only manufactured prior to July, 2010 (Prior to serial number 1007L0001)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Sunrise Medical 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-2014-RN-00012-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-01-08
  • 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-2014-RN-00012-1
  • 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
    Two reported incidences have occurred since the product was first released in december 2004, where the upper base casting has fractured. the looseness or removal of the four screws that locate the base plate to the upper base casting may allow the base casting to be distorted or weakened under load and possibly fracture if excessive force is applied.This recall action undertaken in february 2013 was carried out prior to the approval of the recall strategy by the tga.
  • Action
    Sunrise Medical is advising users that affected units will be upgraded as part of the next scheduled inspection. This action has bee closed-out on 12/02/2016.

Device

Oxford Advance only manufactured prior to July, 2010 (Prior to serial number 1007L0001)
  • Modèle / numéro de série
    Oxford Advance only manufactured prior to July, 2010 (Prior to serial number 1007L0001)ARTG Number: 101303
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd