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
Hot screws from the "heater head" of the iws could fall onto the bed if the "heater head" assembly has been improperly serviced. the attached service manual addendum provides instructions for checking and tightening the screws. during each annual preventive maintenance check continue to ensure that the screws are tight.