Events

Rappel de JCM Compact Base for Neptune and Triton wheelchairs

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 JCM Seating Solutions 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
    19125
  • Date de mise en oeuvre de l'événement
    2015-09-15
  • 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
    Jcm has received reports of isolated incidents involving the instability of the compact base when used in certain conditions. whilst the compact base design in itself is structurally sound and has no mechanical issue, the following guidelines have been revised for safe use:, * the compact base should be used with the neptune size 1 and triton size 0 chairs only, * maximum user weight to compact base should not exceed 40kg., * any seating system larger than the neptune size 1 and triton size 0 should be used with a multi height & tilt base or other approved jcm base/wheelchair base to ensure complete stability.
  • Action
    Instructions for use to be updated

Device

JCM Compact Base for Neptune and Triton wheelchairs

Manufacturer

JCM Seating Solutions Ltd