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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In october 2015 a customer complaint was received where it was reported that during a procedure a false button push occurred while the mrxperion injector was being used with a siemens skyra 3t scanner. it was found that the head user interface assembly was non-conforming due to inadequate/missing shielding applied to the graphic overlay layer of the laminated assembly manufactured by the supplier.