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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Complaints were received from customer sites describing a 4205 error message when the injector is used with a 3t scanner. an investigation showed that the mrxperion injector was susceptible to electromagnetic interference when exposed to radio frequency (rf) energy generated during certain sequences on 3t scanners.