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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During manufacturing process it was discovered that the crimp-connection of a cable was faulty. in case the cable gets loose the high voltage circuit of the system is discharging extremely slow after powering off the system.This error may not lead to any harm to patients or users. the risk remains only to service personnel and only if they do not follow the described procedures for servicing the high voltage circuits in the device.