Events

Rappel de Carina Mobile LiftsAll Models and Series

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Active Medical Supplies 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-00516-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-12
  • 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-00516-1
  • 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, handicare, has identified the possibility that the carina mobile lift could be mounted incorrectly by users in two respects. namely, the lift arm and actuator could be incorrectly mounted and/or the mast with lift arm could be incorrectly mounted.If the connection between lift arm and actuator is incorrectly mounted, there is a possibility that a metal part on top of the actuator (i.E. piston rod eye flange) fractures when subjected to certain weight loads. in the event that the mast is not fully inserted into the mast base and standing upright in a vertical position, there is a possibility that the mast falls forward when subjected to weight load. therefore, there is a risk that an incorrectly mounted mobile lift would cause injury upon use.
  • Action
    Active Medical Supplies is requesting users to follow the additional instructions regarding the inspection of the connection between the lift arm and actuator as well as the positioning of the mast to prevent incorrect mounting of the mobile lifts. The instructions are contained in Annexes A and B (respectively) of the recall notification and are intended to supplement the Instructions for Use (IFU). Users are advised that the updated IFU is available for download from the manufacturer's website.

Device

Carina Mobile LiftsAll Models and Series

Manufacturer

Active Medical Supplies Pty Ltd