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 risk of a data entry error on the spectra optia system that can lead to a safety issue and the actions required to mitigate the risk. this issue can occur if the operator enters the incorrect patient height and/or weight when entering the data on the system.