Events

Rappel de Zippie Zone Wheelchair

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-2018-RN-00160-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-21
  • 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-00160-1
  • 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 zippie zone instructions for use (ifu) have been updated to provide clarification on the intended use and the correct prescription of the wheelchair prior to purchase.
  • Action
    The IFU updates cover the correct usage of the chair and also improved guidance in the correct product selection and client suitability information. Customers with this particular chair model may download the updated instructions at: http://www.sunrisedice.com/asset-bank/assetfile/25518.pdf If users have any concerns regarding the correct usage/application or prescription regarding the chair they have been supplied, it is advised to discuss these concerns with the therapist or supplier in the first instance. Sunrise Medical is also providing a new "Paediatric Prescription Guide" to clients, therapists and clinicians as a reference whilst prescribing and/or assessing clients.

Device

Zippie Zone Wheelchair
  • Modèle / numéro de série
    Zippie Zone Wheelchair Model Number: EIRZ1 ARTG Number: 100167(SUNRISE MEDICAL PTY LIMITED - Wheelchair, )
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd