Health Canada — Medical Devices · Canada · 2017-09-26 · Type II
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Reported risk: This correction decision has been made because of a potential failure of the top plate, which is the component that connects the seating system of the wheelchair to the base. A complete failure of the top plate assembly would result in the chair user and the seating system falling from the base leading to a potential injury. Out of 71 cases reported to the FDA, 3 serious injuries occurred (2 broken bones/1 laceration).
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