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.
데이터 추가 비고
원인
It has been found that the label placed on the affected devices includes incorrect information regarding the input voltage - instead of showing 120v 60hz the one currently on the label is 230v 50hz. the products are technically configured to be compatible with 120v 60hz input voltage therefore the detected problem is unlikely to have any impact on the device operation or performance.