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 supplier found and reported that some of their connector blocks were out-of specification. the defect on the master - side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings and as a result the tilt may cause a potential change to the central axis of the radiation beam. this could affect a system in the event that a connector block was replaced after the last beam alignment check for the fixed collimator housing and iris variable aperture collimator.