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
During our common product monitoring one of our suppliers did inform us about an assembly problem what was recognized internally. in single cases an insufficient crimping at one of the cables of a drive motor was identified. this insufficient crimping may cause bad contacting resulting in high contact resistance. there is potential for system failure as a result of the identified defect. the potential of fire due to heating was not considered. to determine to what extent this insufficient crimping was brought into the field aninspection of the installed base will be performed.