Events

Recall of James Leckey Design Mygo Stander Size 2

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by James Leckey Design Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    20361
  • Event Initiated Date
    2016-07-14
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Recalling Organisation: Allied Medical Ltd, 29 Triton Drive, North Harbour, Auckland
  • Reason
    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