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 dxi instruments are class 1 laser products that use two class 2 laser products (bar code readers) internal to the instrument. as part of an internal review it was determined the dxi instruments are not compliant to standards regarding identification of laser class inspection of laser labels and information in the operator guide and service manual documentation.