Events

Rappel de Sunrise Medical Sunlift 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-2014-RN-01057-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-21
  • 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-2014-RN-01057-1
  • 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
    Sunrise medical is issuing a product notification following the return of 2 hoists model g175 due to the legs moving in an incorrect “v” position.Distributors and consumers are being notified of important new information relating to conditions of use and revised inspection criteria. the revised information covers conditions of use, daily checks, and ongoing maintenance requirements which will reduce possible damage to the hoist legs which in turn may affect the stability of the hoist.
  • Action
    Sunrise Medical is providing an updated user manual and advising users of the correct use of the Sunlift hoist. Sunrise Medical is requesting the customers to check the parallelism of the legs of the hoist. If the legs are toed inwards by more than 3 degrees and not parallel Sunrise is requesting the user not to use the hoist in this position. Sunrise Medical is also providing an interface bracket with fitting instructions to ensure the legs will not turn inwards. The parts will be supplied Free-of-Charge. This action has been closed-out on 18/04/2017.

Device

Sunrise Medical Sunlift Hoist
  • Modèle / numéro de série
    Sunrise Medical Sunlift Hoist Models: G150E & G175EARTG # 101030
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd