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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A partial grid-switch failure may occur in allura xper and integris systems that may result in a higher x-ray dose than expected. this issue may pose a risk for patients or users. the potential failure can lead to a radiation exposure rate in excess of the 11.5 r/min health canada requirement. however it will only occur if the grid switch fails during fluoroscopy examinations using high kv values.