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
Three lots of this power supply were built with a single layer of insulation used in the transformer instead of the 3 layers minimum per product specification. safety regulations require a minimum of 2 layers of insulation in the transformer. these devices may not meet required medical device electrical safety standards and may result in an increased potential for electric shock.