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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A manufacturing defect in the bar electrodes results in not meeting impedance specifications.The lower impedence may lead to lower emg signals.Procedures that rely on standardized emg signals may be affected.