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 affected co2 analyzer modules may experience a problem at the end of the calibration of the capnostat 3 sensor causing the calibration to fail and activate the medium priority alarm "co2 module error" on the user interface of the servo ventilator. this issue only affects the optional co2 analyzer functionality preventing it from displaying any measured co2 values.It has no effect on any other functionality of the ventilator.