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
This recall has been initiated due to merge pacs inability to display presentation states on prior comparison studies generated on 3rd party systems or that have been migrated from office pacs. pacs 6.5.6 introduced the feature to be able to display foreign presentation states however this feature was only available on the primary study in any given viewer instance. it did not apply to prior comparison studies that were opened in the same viewer. users might assume that if the annotations are available in the primary study they would also be shown if available on the prior comparison studies.