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.
데이터 추가 비고
원인
Change made as a preventive action to reduce potential for a costly repair should a failure occur.Action prompted when a hole was worn into distal body of a scope.Lubricant leaked out but poses no health risk.