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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The battery/cable power assemblies in spectris solaris ep mr injection systems (ssep) distributed from september - november 2016 do not meet our specifications. this could result in intermittent power failure of the device which could result in a degraded image or a delay of the imaging procedure requiring a repeat of the contrast-enhanced mr scan should it occur during a procedure.