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.
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Additional addendums sent from enterprise imaging to an external ris/his is sent with the same date/time-stamp in obr-22 (results rpt/status chng - date/time) as the one from the first addendum. this may lead to addendum workflow issues. this issue may lead to the addendum not being stored in the ris/his system and the addendum information not being considered by referring physicians/clinicians when making medical decisions.