Events

Rappel de James Leckey Design Mygo Stander Size 2

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 James Leckey Design 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
    20361
  • Date de mise en oeuvre de l'événement
    2016-07-14
  • 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: Allied Medical Ltd, 29 Triton Drive, North Harbour, Auckland
  • Cause
    James leckey design mygo stander is a 3-in-1 prone, supine and upright stander that supports children with severe disabilities aged 4 to 14 years while standing., it has been identified that the angle adjustment mechanism for the standersmanufactured during a specific period (jan 2012 to august 2013) allows the user to lock out the frame's safety pull pin and adjust the angle using one hand. if the operator's hand slips off the turning handle when a patient is in the frame, the handle could 'self-wind' and spin rapidly as the stander returns to the upright position., if this occurs, while there is no risk to the patient in the frame, there is a small risk that the fast spinning handle could injure the operator if they try to take hold of it., the mechanism design was changed in august 2013 and it is not possible to lock out the safety pull pin in standers manufactured since then. two hands are required to adjust the stander angle in newer models.
  • Action
    Product to be modified

Device

James Leckey Design Mygo Stander Size 2

Manufacturer

James Leckey Design Ltd