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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It was identified that there is potential that an electrical connection in the equipment cabinet has not been installed correctly. in potential fault scenarios (e.G. if several live wires become defective) and under certain conditions this may prevent a safety mechanism on the system side from taking effect thus compromising the electrical safety of the system. the resulting potential hazard situation has not yet occurred. the issue identified is exclusive to systems of type artis q and artis q.Zen.