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 purpose of the recall is to replace data transmission cable (usb-cable) connecting the innocor device with an external computer. the replacement usb cable will provide galvanic isolation of the innocor from the external computer via opto-couplers as opposed to the grounding protection currently in use.