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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Philips has become aware that recent revisions of the device's instructions for use (ifu) (part number 989803162691 rev. f- rev. h) inaccurately indicate "endotracheal" as a body temperature application site. the flextemp reusable temperature sensor is not intended to be used for endotracheal site placement.