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
On november 28 2013 a complaint was reported to the manufacturer indicating that "when opening images for patient 'a' patient 'a' images show but the report shows for a different patient 'b'. cardiologist is looking at the wrong hemodynamic report data.