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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Custom ultrasonics inc. failed to complete validations of the olympus evis exera ii tjf q180v duodenoscope processed in the system 83 plus and the system 83 plus 9 washer disinfectors and failed to complete validation of various high level disinfectants used with the system 83 plus 2 and system 83 plus 9 washer disinfectors.