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
Through a review of complaint data it was identified that the workflow supported by versions 4.21 4.31 and 4.32 of the certegra informatics point-of-care software may fail intermittently to send data captured from the injection system to the institution's pacs system. this failure to send data is more likely to occur when the certegra workstation is left on for more than 24 consecutive hours.