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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Software anomaly related to the recist 1.1 target lesion evaluation criteria in the findings workflow module within the aquarius workstation intuition client viewer. in certain instances this target lesion evaluation output provided by the software may be inaccurate. the total measurement calculation and percentage of change are accurate. the affected versions are 4.4.11.82.6784 4.4.11.116.7134 and 4.4.11.144.7589.