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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An issue with the placement of a capacitor in the h3+ digital holter 48 hour recorders has resulted in reduced battery life causing the recorder to record for less than the expected time. h3+ digital holter recorders with serial numbers between 115110248400 and 115410276012 fail to meet the claim of 24-48 hours recording time.