PRA number
2016/15513
Published date
Product description
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.
Why the product is recalled
The angle adjustment mechanism for James Leckey Design Mygo Standers manufactured during this period 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.
What the hazards are to consumers
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.
What consumers should do
If you or someone you provide care for uses a James Leckey Design Mygo Stander manufactured between January 2012 and August 2013 (see above for affected product codes and serial numbers), be aware of this recall for product correction.
Please note that there is no risk to the patient in the frame and the risk of injury to the user of the angle adjustment mechanism is very small.
You will be contacted by the dealer who supplied your device to arrange installation of the replacement safety pull pin.
If you have any questions or concerns about this issue, or if you think you have an affected device and are not contacted, talk to your dealer or contact Otto Bock Australia on 03 9439 9917.
Please note that there is no risk to the patient in the frame and the risk of injury to the user of the angle adjustment mechanism is very small.
You will be contacted by the dealer who supplied your device to arrange installation of the replacement safety pull pin.
If you have any questions or concerns about this issue, or if you think you have an affected device and are not contacted, talk to your dealer or contact Otto Bock Australia on 03 9439 9917.
Supplier
Otto Bock Australia
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.