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 distributed actiwatch spectrum plus devices were originally classified by respironics as a class 1 rule 12 medical device using the classifications rules for medical devices found in schedule 1 of the medical device regulations. as indicated by health canada the device was deemed to be a class ii device requiring a license prior to product distribution.