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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Sunrise medical (us) llc has observed failure of the original backrest bracket (2009-2013) which can fatigue over the lifetime of the product. when this occurs there is a possibility of the bracket fracturing causing the backrest to detach from the chair frame. the root cause was found to be insufficient material in a high stress area. under certain loading conditions these high stresses can lead to material fatigue and ultimately failure of the bracket.