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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The artwork on the defibrillation electrodes does not meet physio-control's specifications and shows incorrect electrode placement for an infant. there is no issue with the performance or function of the defibrillation electrodes this is limited to incorrect artwork on the defibrillation electrodes within the packaging. the artwork on the electrode packaging shows the correct electrode placement for an infant.