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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Spacelabs healthcare learned through internal testing that the power supply attachment screw may damage an internal component and causes the monitor to not turn on not turn off or involuntarily shut down. the screw used to attach the power supply to the monitor may come into contact with a capacitor on the internal power supply pcba causing the capacitor to crack and the monitor to fail.