James Leckey Design Mygo Stander 의 리콜

Recall

RC-2016-RN-00854-1

Class II

2016-06-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00854-1

It has been identified that the initial design of the angle adjustment mechanism for the stander allowed the user to lock out the safety pull pin on the frame and adjust the angle of the stander using one hand. if the operator’s hand slipped off the turning handle when a patient was in the frame then the handle could “self-wind” and spin rapidly as the stander returns to the upright position. whilst there is no risk to the patient in the frame, the fast spinning handle does pose a risk of injury to the operator if they try to take hold of the handle.These issues only impact devices manufactured between january 2012 and august 2013 as the design of the pull pin safety mechanism was changed in august 2013. it is no longer possible to lock the pull pin out and two hands are now required to adjust the stander angle.

Otto Bock is arranging for distributors to contact users of the affected devices and arrange for replacement of the pull-pin on the device with one that cannot be locked by the operator. 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. For more information, please see https://www.tga.gov.au/alert/james-leckey-design-mygo-stander .