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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The c-series ximatron uses a lead screw drive assembly system for the focus to axis movement and for the image intensifier vertical movement. under normal use these drive systems will wear and eventually require replacement. however failure to monitor the extent of the wear of the lead screw drive assemblies could lead to a failure of the lead screw drive system. this could potentially lead to a free floating drive system that could slide on the captive gantry rails during gantry rotation when operating one or both of these drive systems potentially leading to a collision with a patient an operator the floor or the treatment table.