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.
See a list of details to help identify the product
Reason 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.
The hazards 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.
Details to help identify the product
Supplier running the recall
Otto Bock Australia
Identifying product features
Mygo Stander Size 1
Product code:143-1600
Serial number range: LEC/087023 to LEC/108416
Month of manufacture: January 2012 to August 2013
Mygo Stander Size 2
Product code:143-2600
Serial number range:LEC/087023 to LEC/108416
Month of manufacture: January 2012 to August 2013
Identifying numbers
Other identifying numbers
Mygo Stander Size 1
Product code:143-1600
Serial number range: LEC/087023 to LEC/108416
Month of manufacture: January 2012 to August 2013
Mygo Stander Size 2
Product code:143-2600
Serial number range:LEC/087023 to LEC/108416
Month of manufacture: January 2012 to August 2013
Product code:143-1600
Serial number range: LEC/087023 to LEC/108416
Month of manufacture: January 2012 to August 2013
Mygo Stander Size 2
Product code:143-2600
Serial number range:LEC/087023 to LEC/108416
Month of manufacture: January 2012 to August 2013
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2016/15513 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.