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.
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Product monitoring has revealed a possible defect in the x-ray tube cooling device in the affected systems. the input fuse of the cooling device can be damaged when the system is switched on. the cooling device is therefore no longer available for cooling the tube at the start of a procedure. this information is displayed to the user but a procedure can be started nonetheless. however the x-ray tube can fail after a certain time and radiation will no longer be available.