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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Changes to the instructions for the leak test method specified for all fujifilm endoscopes in the cleaning disinfection and storage operation manuals as well as the operation manuals for the air leak tester lt-7f were made to ensure consistency with the iso 8600-7 standard. specific requirements added were to conduct the submersion test for the duration of at least one minute and using a water temperature range of 10 degrees celsius to 40 degrees celsius.
SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - GASTROSCOPE;SIGMOIDSCOPE;COLONOSCOPE EC;SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - BRONCHOSCOPE;DOUBLE BALLOON METHOD ELECTRONIC ENTEROSCOPY SYSTEM - ENTEROSCOPE;SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYST