Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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When sitting the prosthetic foot can go into the 'relief function' to move the footplate towards the ground if this function is not switched off or if the foot is in stand-by mode. when operating machines with foot pedals the possibility is given that the foot - unnoticed by the user - activates the 'relief function' and for example get stuck under the foot pedal. the foot pedal can be blocked and this could lead to a hazardous situation. also an ios software issue has been identified where the restricted range for dorsiflexion in the 'relief function' does not save when the re-training is done via ios galileo application.