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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A complaint with a system in which the inability to perform rotational angiography occurred twice. the cause was traced to a sensor in the magnus column as a result of an incorrect signal from this sensor all high-speed movements of the c-arc were blocked. an incorrect signal can have an effect during high-speed applications of the allura system (3dra xperct xperswing). if the fault occurs during daily xperct calibration this function will not be available. if the fault occurs prior to or during a high-speed application the acquisition cannot be set-up and the movement function of both the c-arc and the magnus operating table are locked. the described fault does not affect other functions of the system.