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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Under rare environmental conditions (i.E. extremely dry air in combination with a highly isolated floor) electrostatic discharges (esd) >8 kv at the system control console may trigger an unintended movement of the system which may cause an emergency situation danger to the patient (e.G. falling off the table squeezing) to operating personnel or to the unit.