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 a technical review it was found that axiom artis systems with a certain serial number are using a flat detector cooling unit with inappropriate connectors that may possibly leak. this might cause a system failure which may possibly result in a drop out of the gantry system. this update does only affect systems of a specific production series.