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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There have been reports of a burning smell/smoke coming out from the upper ventilation grids of the artis dialysis machine. the events have been associated with a limited number of power supply units manufactured with a specific batch of capacitor. the technical analysis identified that the issue was caused by a defective capacitor inside the power supply unit which has the potential to melt after approximatively 4 years of use.