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Consumers and health professionals are advised that Otto Bock Australia, in consultation with the TGA, is undertaking a recall for product correction for James Leckey Design Mygo Standers manufactured between January 2012 and August 2013.
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 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.
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.
Please note that 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.
This recall for product correction is being undertaken to replace the safety pull pin on the device to eliminate the identified risk. The replacement safety pull pin will require the user to hold the pull pin with one hand while turning the adjustment handle with the other hand. If their hand slips off the turning handle, they can simply release the pull pin and the handle will stop winding.
The affected products and serial numbers are:
| Product name | Product code | Serial number range | Month of manufacture |
|---|---|---|---|
| Mygo Stander Size 1 | 143-1600 | LEC/087023 to LEC/108416 | January 2012 to August 2013 |
| Mygo Stander Size 2 | 143-2600 | LEC/087023 to LEC/108416 | January 2012 to August 2013 |
Information for consumers
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.
Information for health professionals
If you are treating a patient who uses an affected James Leckey Design Mygo Stander, please make sure they are aware of this issue.
If they have not been contacted about this recall for product correction, advise them to contact the dealer who supplied their device. If they have any difficulties, they can call Otto Bock Australia on 03 9439 9917.
Reassure them 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.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.