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 problem was discovered internally with a supplied component for the affected products. when a smart check by roho is used to perform a smart setup with one of the affected cushions the nonconforming part may adversely affect the setup process resulting in an improper cushion setup.