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 exist a potential of malfunction and hence hazard to patients and personnel when exposing the tableside control panel of the luminos drf system to fluids. in case of exposure to fluids the tableside control panel may be infiltrated by fluids. as a result malfunctions of the tableside control panel may occur when buttons on the control panel are pressed.