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
Srs treatments occurred with conical collimator accessory not inserted or with conical collimator accessory correctly mounted but with a primary collimator field size setting exceeding outside diameter of that conical collimator. with wrong field size unintended radiation is given to patient outside the outer edge of cone.