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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It has been determined that some drive stand bolts may fail to meet mechanical specifications. these load - bearing stand bolts are used to secure the drive stand assembly to the base frame. failure of some of the gantry stand rear bolts may lead to a shift of the linear accelerator isocenter. the affected bolts were isolated to a single lot of bolts supplied to varian.