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 optical guidance platform may not be properly enforcing a 24 hour time limit between optical camera recalibrations. the optical guidance camera has not been evaluated for stability beyond a 24 hour time period and must be recalibrated at least once every 24 hours. this issue is most likely to be found in units upgraded to the 2.6.X software as older versions of the software allowed users to set calibration time outs greater than 24 hours. however all users should check their settings as described. in particular this issue may be found in sonarray systems where users may have increased the calibration time out beyond the factory settings.