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 fan assembly for specific system 98/98xt cs100/cs100i and cs300 iabps could potentially contain a misshapen retaining ring. this retaining ring could disengage within the fan assembly causing the fan to stop rotating which causes the power supply to overheat and the iabp to shut down without any visual or audible warning.