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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There is an anomaly in the ecg software that fails to detect low heart rates in the range of 12 to 15 bpm under some unusual conditions. only one report has been received regarding this anomaly.