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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As a result of user error complaints regarding injuries resulting from collimator change siemens has determined that for e.Cam or symbia e systems although the existing user manual is correct additional supplemental instructions with the inclusion of visual aids may further clarify and emphasize the proper collimator change process. a customer advisory notice is being issued to advise customers that siemens is providing an addendum to the symbia e and e.Cam user manual with specific enhancements to the instructions for collimator change. incidents during collimator change may be avoided by operators properly following specified instructions.