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 discovered that the system - in certain rare but possible combinations of user behavior (in zoom modes 30x30 and 15x15 only but not in other zoom modes and only in cases with manual override outside the operator's working location) - does not provide the appropriate audible signal permanent activation and manual override although the system is in high-level control functionality.