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
A routine internal quality check has found that the pt 4000 is fitted with a 16 amp fuse instead of the specified 1.6 amp rating. this may mean that the internal fuse does not trip promptly in the event of an internal short-circuit with the possible consequence that the ward panel circuit-breaker may be tripped first or the device may severely overheat.