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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Gendex received customer complaints alleged that images taken with the orthoralis 9200 dde panoramic dental x-ray systems were either distorted fragmented flipped negative reversed or had lines across them. the image distortion could not be used for diagnostic purposes.