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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If user fails to secure the cable to the temple arm of his/her loupes with the spiral temple clip provided with the device strain on the cable(cable pull forces in excess of 7lb) where it interfaces to the headlight may result in an electrical open that prevents power from reaching the headlight led.