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 come to the manufacturer's attention that in isolated incidences the user continues to use the device if the keypad has been broken or is damaged. the damage to the keypad could possibly be caused by wear and tear the ingress of aggressive cleaning solutions or by abuse such as pressing the buttons with sharp objects like a pen tweezers or long finger nails. this could cause the internal circuitry of the keypad to become exposed which could potentially lead to an electric shock if the keypad and the electrodes are handled simultaneously. the occurrence of such phenomena is not a direct malfunction of the device but rather due to negligence.