Events

Retiro De Equipo (Recall) de James Leckey Design Mygo Stander Size 2

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por James Leckey Design Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    20361
  • Fecha de inicio del evento
    2016-07-14
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Recalling Organisation: Allied Medical Ltd, 29 Triton Drive, North Harbour, Auckland
  • Causa
    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.
  • Acción
    Product to be modified

Device

James Leckey Design Mygo Stander Size 2

Manufacturer

James Leckey Design Ltd