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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Masimo has identified specific lots of sensors that were manufactured with incompatible configurations. this could result in sensors that will either not provide readings for the spco and spmet parameters or inaccurate readings. the specific behavior will depend on the firmware version of the technology board in the device. spco measurements when displayed could be incorrectly elevated throughout the measurement range. spmet measurements above 6% could be affected by a negative bias of 1.5% on average.