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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Bios determined on may 17th 2017 that in a limited number of thermi250 radiofrequency systems the "pause" button shown in the software operating view is not working as intended when pressed based on investigation into a reported event. in these affected systems when the user presses the "pause" button the generator will continue to emit rf energy and the user may not take the necessary safety precautions to avoid micro-discharges as described in the user's manual.