Events

Rappel de Oxford Dipper Hoist

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-2017-RN-01233-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-18
  • 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-01233-1
  • 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
    The manufacturer joerns healthcare has revised the service life statement and related manufacture guidance for the oxford dipper hoist. it is possible that issues such as corrosion can occur rapidly in units older than 7 years and this may not be externally visible to users. joerns healthcare strongly recommends load testing for the oxford dipper is carried out at each and every 6 monthly inspection due to the hostile environment in which it resides and operates. the humid and corrosive nature of the pool-side locations can potentially lead to product deficiencies that may otherwise remain undetected.
  • Action
    Load testing for the Oxford Dipper should be carried out at every six-monthly inspection The Oxford Dippers that are older than 7 years need to be changed out prior to the following scheduled (6 monthly) inspection to ensure the ongoing safety of users. Recipients are requested to contact all customer(s) supplied with the supplied serial numbers, then complete the supplied Receipt Form with the appropriate box checked, according to disposition of each hoist as soon as the information becomes available or the change out is complete.

Device

Oxford Dipper Hoist
  • Modèle / numéro de série
    Oxford Dipper Hoist Models: OP10013, OP10014, X10013 and X10014Purchased between 2001 and 2010Multiple Serial Numbers affectedARTG Number: 101030
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd