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
During radiotherapy planning the hi-art (ver 4.0 and 4.0.1 software) system updates the imported diagnostic ct couch image portion of the patient's image to the hi-art radiotherapy couch. in some cases the patient's diagnostic ct image is narrower than the hi-art radiotherapy couch image. in these cases the patient's diagnostic ct must be increased in width to accommodate the hi-art radiotherapy couch width. this may result in the patient's regions of interest contours being shifted laterally from the intended position by up to 5mm.