Events

Rappel de Mobile Shower and Toilet Commode Aquatec Ocean VIP

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Invacare Australia 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-00518-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-05-20
  • 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-00518-1
  • 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 has advised that during regular market observation they noticed that some of the snap-on fixtures do not withstand the required pull out force. this was caused due to an inconsistency of the injection moulding, and did not meet the design specification for the snap-on fixtures. the male portion of the clip has a 90-degree angle overhang; and this was not completely filled as per specification. the attachment mechanism has the potential to unintentionally open when the product is used in the recline position.
  • Action
    Invacare is requesting the device providers to locate all affected Mobile Shower and Toilet Commode Aquatec Ocean VIP and replace the faulty clips. Further information on this recall action can be found on the TGA website at http://www.tga.gov.au/safety/alerts-device-aquatec-ocean-vip-mobile-shower-toilet-commode-140522.htm . This action has been closed-out on 04/04/2017

Device

Mobile Shower and Toilet Commode Aquatec Ocean VIP
  • Modèle / numéro de série
    Mobile Shower and Toilet Commode Aquatec Ocean VIPMultiple serial numbers affectedARTG Number: 153914
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd