Events

Rappel de RMS SIMBA Buggy

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Rehabilitation Manufacturing Services 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
    18121
  • Date de mise en oeuvre de l'événement
    2015-02-18
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Medifab Medical Fabrication, 32 Detroit Drive, Izone Business Hub, Rolleston 7675
  • Cause
    Manufacturer has been made aware that frame components are substandard and have the potential to fail in use potentailly endangering the health of the user. the frame knuckle joints, found on each side of the simba logo sticker, have been produced using an incorrect method of manufacture causing a reduction in component strength and must be replaced to ensure continued safe use of the product.
  • Action
    Product to be exchanged

Device

RMS SIMBA Buggy

Manufacturer

Rehabilitation Manufacturing Services Ltd