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
Software anomaly seen with eclipse electron monte carlo (emc) algorithm where no-equidistant data points in the open beam profile used during configuration may lead to inaccurate results. in a customer report seen (where no patients were involved) beam data collection with non-equidistant data points can lead to inaccurate dose distributions in the treatment plan. the sample dataset from the customer showed a 30% dose difference between the treatment plan isodose plot and the actual delivered dose.