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
Siemens is informing customers about an upcoming update to their symbia systems whereby the supplier inadvertently used a 10a fuse instead of the 4a fuse specified in the product design. this improper amperage rating was installed on symbia systems with manufacturing dates prior to july 1 2014. these fuses in conjunction with a specific failure mode of the power controller assembly could lead to the overheating of the assembly.