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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The hand switch used with a specific sequence of procedure steps has been observed to intermittently cause the injector to erroneously stay in injection test mode which may alter safety features. consequently the injection may result in an over delivery of contrast media equivalent to the programmed post flush volume.