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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When performing sonication with the sonalleve mr-hifu fibroid therapy system (with r2.1 l3 application software) with treatment cells of 2mm in size there is a possibility that the depth of sonication is not shown on the user interface due to a software defect. a maximum positioning error of 4cm in longitudinal direction is possible. this may occur either in the uterine fibroid or the bone application.